MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-13 for AMMONIA AM1054 manufactured by Randox Laboratories, Ltd..
[5672375]
Patient sample will recover with a positive bias of approximately 60 umol/l when using ammonia catalogue number am1054 batch 326180. All affected customers have been contacted and instructed to discontinue use and discard, their inventory will be replaced. The ammonia test is generally ordered along with glucose, urea, electrolytes, kidney and liver functions tests alp, ast and alt therefore it is not considered a single conclusive diagnostic test to initiate therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020890-2015-00002 |
| MDR Report Key | 4692040 |
| Report Source | 06 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-02-02 |
| Date of Event | 2015-01-19 |
| Date Mfgr Received | 2015-01-19 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-05-27 |
| 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 | 0 |
| Manufacturer Street | 55 DIAMOND RD. |
| Manufacturer City | CRUMLIN, COUNTY ANTRIM |
| Manufacturer Country | UK |
| Manufacturer Phone | 894422413 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMMONIA |
| Generic Name | AMMONIA |
| Product Code | JIF |
| Date Received | 2015-04-13 |
| Model Number | NA |
| Catalog Number | AM1054 |
| Lot Number | 326180 |
| ID Number | NA |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RANDOX LABORATORIES, LTD. |
| Manufacturer Address | 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-13 |