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 2017-11-14 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[93097702]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93097703]
The customer received a questionable high astl aspartate aminotransferase result for one patient sample. The initial result was 248 u/l with a data flag and was reported outside of the laboratory. The physician questioned the result and the sample was repeated with a result of 44 u/l. The repeat result was believed to be correct. The patient was not adversely affected. The reagent lot number was 223106. The expiration date was requested but was not provided. The patient's alp and alt were also repeated and the results matched the original results. The customer performed a precision study for ast using a patient sample and had no issues. The field service representative found precipitant on the rinse nozzle. He cleaned the rinse nozzle, checked the gear pump and system for contamination, and checked all levels. Precision testing and qc was performed and was acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02599 |
| MDR Report Key | 7028186 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-14 |
| Date of Report | 2017-11-14 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2017-11-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CIT |
| Date Received | 2017-11-14 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| 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 | 2017-11-14 |