| TGA Action ID |
RC-2025-RN-00360-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
epoc BGEM BUN Test Card. An in vitro diagnostic medical device (IVD)
Catalogue number: 10736515
Lot number: All lot numbers with prefix (xx) 02 or 12
Software version & sensor configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n
Expiry date: 10 June 2025 |
| ARTG Number |
198588 |
| Unique Device Identifier (UDI) |
00809708121860 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of discrepant high pH results in samples introduced with higher injection volumes (beyond the epoc Reader beep or after the "Analyzing Sample" message is displayed) with epoc sensor configuration 45.n (software version: epoc Host v3.41.2 and epoc NXS v4.14.9 & 4.14.11).
Discrepant high pH results may affect the following calculated values:
- Anion Gap (AGap) (through cHCO3 or TCO2)
- Base Excess (blood) (BE(b))
- Base Excess (extra cellular fluid) (BE (ecf))
- Calculated Bicarbonate (cHCO3-)
- Calculated Oxygen Saturation (cSO2)
- Calculated Total Carbon Dioxide (cTCO2).
Falsely elevated pH values may lead to unrecognised acidosis and/or the misinterpretation of acid-base disorders which could result in suboptimal management decisions.
The potential for injury based on a calculated parameter or the measured TCO2 is not significantly increased when the pH is erroneous because these would not be used in isolation to guide clinical decisions. |
| Instructions for Customers/Users |
Higher injection volumes (beyond the Reader beep or after "Analyzing Sample" message) can cause erroneous pH results. Customers should stop injecting as soon as audio/visual cues are presented.
The current software version/sensor configuration expires on June 10, 2025. A new sensor configuration will be released in April/May 2025 to resolve high pH discrepancies on epoc systems running sensor configuration 45.n. Customers should install the update promptly.
Customers are to review the Customer Letter with their Medical Director to determine the appropriate course of action, including for any previously generated results.
This action has been closed out on 28/01/2026. |
| Action Commencement Date |
31/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |