MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-02-10 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[67285471]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67285472]
The customer stated that they received an erroneous result for one patient sample tested for ua2 uric acid ver. 2 (uac2) on a cobas 6000 c (501) module - c501. The erroneous result was reported outside of the laboratory. It was stated that the low result did not fit the clinical picture of the patient. The sample initially resulted as 0. 026 mmol/l. The date of initial testing was not provided. The sample was collected on (b)(6) 2017. The sample was repeated, resulting as 0. 269 mmol/l on (b)(6) 2017. The patient was not adversely affected. The uac2 reagent lot number was 172896. The reagent expiration date was asked for, but not provided. The mixer was found to be within specifications. Calibrations were within acceptable limits and controls were within specifications. Samples were tested from primary tubes which were processed on a cobas p612 pre-analytics system.
Patient Sequence No: 1, Text Type: D, B5
[68569228]
Medwatch field d4 serial number has been updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00269 |
| MDR Report Key | 6321972 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-01-17 |
| Date Added to Maude | 2017-02-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDH |
| Date Received | 2017-02-10 |
| Model Number | C501 |
| Catalog Number | ASKU |
| 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 462500457 US 462500457 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-10 |
| Model Number | C501 |
| Catalog Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-10 |