MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-07-21 for COBAS 6000 C501 MODULE 04745914001 manufactured by Roche Diagnostics.
[6432516]
The customer received a questionable albumin gen. 2 result for one patient sample. As other results for the sample had data flags indicating there was a clot in the sample, the customer questioned why the erroneous result was not flagged. The initial result was 0. 008 and was reported outside the laboratory. The sample was repeated and the result was 40. 571. No units of measure were provided. The patient was not adversely affected. The albumin reagent lot number and expiration date were requested, but were not provided.
Patient Sequence No: 1, Text Type: D, B5
[14243954]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[24989315]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03838 |
| MDR Report Key | 4928466 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-07-21 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-07-03 |
| Date Mfgr Received | 2015-07-03 |
| Date Added to Maude | 2015-07-21 |
| 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 |
| 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 | DCF |
| Date Received | 2015-07-21 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 46250 US 46250 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-07-21 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-21 |