MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-08 for AMMONIA 20766682322 manufactured by Roche Diagnostics.
[15425244]
The customer received questionable results for ammonia (nh3) on one patient sample. The customer currently runs the nh3 assay on the cobas 6000 c501 (c501) module, and was validating the assay on the modular p (modp) instrument at the time of the event. The initial nh3 result from the c501 was 285 umol/l and was reported outside of the laboratory. The sample was then run on the modp and generated a result of 66 umol/l. The sample was repeated again on the modp and generated a result of 121. 9 umol/l. The sample was then repeated on the c501 and generated a repeat result of 73. 3 umol/l. The customer deemed the result of 73. 3 umol/l to be the correct result and issued a corrected report. There was no adverse event. The lot number of nh3 reagent in use was 67213901, with an expiration date of 05/31/2014. The field service representative found that the ultrasonic mixer (usm) r3 needed to be changed. He replaced the usm r3, performed the mixing check and cleaned the other usms, which had a build up within them. He also checked the tubing and rinsing of the rinse mechanism, probes and alignments along with the vacuum and water pressures. He performed a precision and accuracy check, with all results within specification. He also performed a blank calibration and the qc was within the customer's specification.
Patient Sequence No: 1, Text Type: D, B5
[15784558]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[18153877]
A specific root cause could not be identified. The ammonia assay is sensitive to environmental influences and can be immediately impacted by the environment. This is described in product labeling. Based upon information provided, the issue appears to be related to the reagent pack and not the mixer issues found by the field service representative. Mixer issues would have impacted additional assays.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-06161 |
| MDR Report Key | 3393956 |
| Report Source | 05,06 |
| Date Received | 2013-10-08 |
| Date of Report | 2013-10-28 |
| Date of Event | 2013-09-23 |
| Date Mfgr Received | 2013-09-23 |
| Date Added to Maude | 2013-10-08 |
| 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 | AMMONIA |
| Generic Name | ENZYMATIC METHOD, AMMONIA |
| Product Code | JIF |
| Date Received | 2013-10-08 |
| Model Number | NA |
| Catalog Number | 20766682322 |
| Lot Number | 67213901 |
| ID Number | NA |
| Device Expiration Date | 2014-05-31 |
| 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 | 2013-10-08 |