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 2015-06-16 for ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION 20764949322 manufactured by Roche Diagnostics.
[5872977]
The customer received questionable aspartate aminotransferase (ast) results for one patient from a cobas c501. (b)(6) 2015: 311 u/l 02/21/2015: 551 u/l 10/09/2013: 291 u/l it was uncertain if these results were generated from the same patient sample. With the sample that generated the result of 311 u/l, the customer performed precipitation with peg5000: sample with peg5000 25% in pbs (1)- <10 u/l sample with peg5000 25% in pbs (2)- <10 u/l %ppa 96. 8% (ppa ref 18-53 %). The results were reported outside the laboratory. The patient was not adversely affected. The customer suspected the presence of a macroenzyme, one complexed with an immunoglobulin and ast.
Patient Sequence No: 1, Text Type: D, B5
[13481746]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[22562626]
A specific root cause could not be identified. Based on the provided data, it was determined the test measured the correct amount of ast in the patient sample which was elevated due to possible macro enzymes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03640 |
| MDR Report Key | 4846629 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-16 |
| Date of Report | 2015-08-04 |
| Date of Event | 2015-04-06 |
| Date Mfgr Received | 2015-05-28 |
| Date Added to Maude | 2015-06-16 |
| 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 MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| 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 | ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION |
| Generic Name | NADH OXIDATION/NAD REDUCTION, AST/SGOT |
| Product Code | CIT |
| Date Received | 2015-06-16 |
| Model Number | NA |
| Catalog Number | 20764949322 |
| Lot Number | 61168 |
| ID Number | NA |
| Device Expiration Date | 2016-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-06-16 |