MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-09 for AMMONIA 20766682322 manufactured by Roche Diagnostics.
[3162152]
The customer experienced issue with ammonia results for an unknown number of patient samples from cobas c501 serial number (b)(4). Of the data provided, only the results for one patient were discrepant and reported outside the laboratory. All results are in umol/l. The initial result was 104 and was reported outside the laboratory. The nurse questioned the result as the patient was receiving lactulose to lower the patient's ammonia level and they did not expect the result to be higher than the patient's previous result. The sample was repeated the original analyzer with two different reagent cassettes. The result from the first cassette was (103. 7) 104 and the result from the second cassette was 64 with a data flag. The sample was also repeated on another cobas c501 analyzer at the site and the result was 104. The patient was redrawn and two samples were received. On the original analyzer, the result from the first tube with the first reagent cassette was 97. 7. The result with the second reagent cassette was 48. 8 with a data flag. The second tube was tested on the other cobas c501 analyzer at the site and the result was 49. This result was believed to be correct and a corrected report was issued. Due to the erroneous result, the doctor had increased the lactulose dose. It was administered to the patient just before the corrected result was reported. No adverse event occurred due to this treatment. The customer refused a service visit and stated she believed the issue was due to the reagent.
Patient Sequence No: 1, Text Type: D, B5
[10810618]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-02836 |
| MDR Report Key | 3102535 |
| Report Source | 05,06 |
| Date Received | 2013-05-09 |
| Date of Report | 2013-05-09 |
| Date of Event | 2013-04-25 |
| Date Mfgr Received | 2013-04-25 |
| Date Added to Maude | 2013-05-09 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 2013-05-09 |
| Model Number | NA |
| Catalog Number | 20766682322 |
| Lot Number | 67213901 |
| ID Number | NA |
| Device Expiration Date | 2014-05-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2013-05-09 |