MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-16 for ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED 20764949322 manufactured by Roche Diagnostics.
[77846336]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77846337]
The customer received questionable astl aspartate aminotransferase results for one patient sample. The initial result was 62 u/l with a data flag indicating a high absorbance value. The automatic repeat result was 66 u/l which was auto-verified and reported outside the laboratory. There were flags on other results for the same sample indicating hemolysis. The customer questioned why the initial ast result did not also have the flag indicting hemolysis. It was explained to the customer that only one flag is displayed and the flag indicating the high absorbance value overrides the hemolysis flag. The patient was discharged and was then redrawn on (b)(6) 2017. The ast result was 39 u/l. The patient was redrawn on (b)(6) 2017 and the ast result was 45 u/l. The customer then believed the reported result of 66 u/l to be incorrect. The customer thought the hemolysis had some impact on the result, but did not think it was enough to be clinically significant. The patient was not adversely affected. The customer declined a service visit. The customer used cobas 6000 c (501) module serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[132606446]
The investigation confirmed the analyzer flagged the results as appropriate. There was no malfunction of the device. An issue with the sample was detectable as the hemolysis index result of 280 was visible to the customer. Per product labeling for the assay, there is no significant interference only up to a hemolysis index of 40. The interference of the hemolysis caused the high result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01245 |
| MDR Report Key | 6646129 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-16 |
| Date of Report | 2017-07-27 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-26 |
| Date Added to Maude | 2017-06-16 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED |
| Generic Name | NADH OXIDATION/NAD REDUCTION, AST/SGOT |
| Product Code | CIT |
| Date Received | 2017-06-16 |
| Model Number | NA |
| Catalog Number | 20764949322 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-16 |