MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-07-27 for COBAS INTEGRA AMMONIA 150 20766682322 manufactured by Roche Diagnostics.
[2844777]
The customer alleged they received a questionable ammonia result on their c501 analyzer. The patient's sample was aliquoted into a false bottom tube before testing. The initial ammonia result was 202. 4 umol/l. The result was telephoned to the doctor whom immediately questioned the result. The customer stated the initial result was held by the cobas it 3000 and not officially released from the laboratory. The customer stated the sample was repeated about 20 minutes later. The repeat results were 64. 7 umol/l and 63. 5 umol/l. The doctor was contacted and was happy with the amended result. As a precaution, another sample was taken from the patient and measured in duplicate. The results agreed with the re-runs of the first sample and were around 60 umol/l. The patient did not have its treatment altered in any way in response to the discrepant result. The ammonia reagent lot number was 653922 and the expiration date was 05/30/2013. The reaction monitor for the discrepant result was overlaid onto the repeat results and showed similar kinetics.
Patient Sequence No: 1, Text Type: D, B5
[10054562]
This event occurred in (b)(6). No information was provided on the specific part number involved in this event.
Patient Sequence No: 1, Text Type: N, H10
[10480128]
The investigation determined this issue is most likely due to decomposition of the reagent. The workaround is to mix and recalibrate the reagent cassette prior to performing any measurements. In addition, the customer set up a rule in their software which will trigger a rerun if initial ammonia results are too high.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-03879 |
| MDR Report Key | 2673245 |
| Report Source | 01,05,06 |
| Date Received | 2012-07-27 |
| Date of Report | 2012-12-18 |
| Date of Event | 2012-07-24 |
| Date Mfgr Received | 2012-07-24 |
| Date Added to Maude | 2012-07-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA AMMONIA 150 |
| Generic Name | ENZYMATIC METHOD, AMMONIA |
| Product Code | JFJ |
| Date Received | 2012-07-27 |
| Model Number | NA |
| Catalog Number | 20766682322 |
| Lot Number | 653922 |
| ID Number | NA |
| Device Expiration Date | 2013-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-27 |