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.
[19653812]
The investigation could not determine a specific root cause, but bacterial contamination of the instrument was most likely the cause. Although the bacterial cultures did not show any growth, decontamination of the instrument and frequent maintenance actions improved the situation. No adverse event was reported.
Patient Sequence No: 1, Text Type: N, H10
[22096871]
The user received a questionable ammonia result for one patient sample from the cobas c501 analyzer. The initial result was 203. 5 ug/dl with a data flag and was reported outside the laboratory as 204 ug/dl. The repeat result was 44. 8 ug/dl. The patient was not adversely affected and the doctor believed the repeat result to be correct.
Patient Sequence No: 1, Text Type: D, B5
[22130817]
It was unknown if the initial reporter sent report to the fda. This event occurred in taiwan.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02305 |
| MDR Report Key | 2072083 |
| Report Source | 01,05,06 |
| Date Received | 2011-04-28 |
| Date of Report | 2012-01-18 |
| Date of Event | 2011-04-07 |
| Date Mfgr Received | 2011-04-07 |
| 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 | 2012-05-31 |
| 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 |