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 2017-01-25 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[65684146]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[65684147]
The customer received a questionable d-di tina-quant d-dimer result for one patient sample. The initial result was 0. 00 ug/ml with a data flag and the repeat result was 10. 39 ug/ml with a data flag. The customer repeated the sample with a decreased sample volume and the result was 12. 12 ug/ml. The customer stated they were going to report this result. The patient was not adversely affected. The customer stated the patient was dead upon arrival and her liver enzyme results were very high. They were able to revive the patient and transfer her to another hospital. The transfer was prior to any of the results being generated. The reagent lot number was 15175101. The expiration date was requested but was not provided. The customer refused a service visit and stated there was no instrument issue. Serum indices on the sample were fine. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. A preanalytic issue was a likely cause of the event. The customer's centrifuge parameters may not have been adequate. As issues were found in the provided qc data where level 1 was out of specification according to the qc manufacturer's stated range, an issue such as a sample needle blocked by gel, a maintenance issue, or wrong handling of the qc material was possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00129 |
| MDR Report Key | 6275591 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-24 |
| Date of Event | 2017-01-06 |
| Date Mfgr Received | 2017-01-06 |
| Date Added to Maude | 2017-01-25 |
| 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 | 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 | 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 | MIF |
| Date Received | 2017-01-25 |
| 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 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-01-25 |
| 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 | 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 | 2017-01-25 |