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 2011-04-28 for AMMONIA 20766682322 manufactured by Roche Diagnostics.
[1945286]
The user experienced an ongoing issue with questionable ammonia results from cobas 6000 analyzer serial number 0809-24 and provided data which was generated on 04/04/2011. Patient sample 1 initial result was 317. 3 umol/l with a data flag and the repeat result was 54. 5 umol/l with a data flag. Patient sample 2 initial result was 154. 8 umol/l and the repeat result was 38. 1 umol/l with a data flag. Patient sample 3 initial result was 323. 7 umol/l and the repeat result was 41. 3 umol/l. No adverse events were alleged regarding the issue.
Patient Sequence No: 1, Text Type: D, B5
[9031116]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9246041]
The investigation of the reaction monitor for one of the elevated results indicated some sort of reagent carry-over which could have led to the falsely high result. Carry-over could have occurred under routine conditions if the instrument was not well-maintained. Extra wash cycles were installed and no further events have been reported.
Patient Sequence No: 1, Text Type: N, H10
[15496218]
New information was provided which changed the date received by manufacturer. The date received by the manufacturer was (b)(6) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02308 |
| MDR Report Key | 2072082 |
| Report Source | 01,05,06 |
| Date Received | 2011-04-28 |
| Date of Report | 2011-07-22 |
| Date of Event | 2011-03-31 |
| Date Mfgr Received | 2011-03-31 |
| Date Added to Maude | 2011-04-28 |
| 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 RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| 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 | 2011-04-28 |
| Model Number | NA |
| Catalog Number | 20766682322 |
| Lot Number | 635969 |
| ID Number | NA |
| Device Expiration Date | 2012-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-04-28 |