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 2011-07-01 for AMMONIA 20766682322 manufactured by Roche Diagnostics.
[18738654]
Requested information was not provided for further investigation. A root cause could not be determined. According to the customer, the issue has not recurred. The initial low ammonia result was not reported outside of the laboratory. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: N, H10
[19104253]
The customer received questionable ammonia results for one patient sample when tested on a cobas 6000 c501 analyzer, serial number (b)(4). The initial result was 3. 1 umol/l. The sample was repeated on the same analyzer and recovered 22 umol/l. The sample was repeated on another cobas 6000 c501 analyzer (serial number was not provided) and recovered 68 umol/l. It is unknown which results were reported outside the laboratory. No adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
[19118454]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03594 |
| MDR Report Key | 2147752 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-08-19 |
| Date of Event | 2011-06-17 |
| Date Mfgr Received | 2011-06-17 |
| Date Added to Maude | 2011-07-01 |
| 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 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 | CATALYTIC METHODS, AMYLASE |
| Product Code | JFJ |
| Date Received | 2011-07-01 |
| Model Number | NA |
| Catalog Number | 20766682322 |
| Lot Number | 629610 |
| ID Number | NA |
| 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 | 2011-07-01 |