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 2017-08-24 for COBAS 8000 C 702 MODULE C702 manufactured by Roche Diagnostics.
[86008011]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86008012]
The customer complained of erroneous results for 1 patient sample tested for alt alanine aminotransferase acc. To ifcc without pyridoxal phosphate activation (alt) and ast aspartate aminotransferase acc. To ifcc without pyridoxal phosphate activation(ast) on two cobas 8000 c 702 modules. Erroneous results were reported outside of the laboratory. This medwatch will cover c702 module with serial (b)(4) (c702 module b). Refer to medwatch with (b)(6) for information on the c702 module with serial (b)(4) (c702 module a) erroneous results. (b)(6). There was no allegation that an adverse event occurred. The last monthly maintenance prior to the event was performed on 06/19/2017 where cuvettes and the photometer were replaced. Calibration and quality controls were acceptable. A specific root cause was not identified. Additional information was requested for investigation but was not provided. Since calibration and qc were acceptable, both an instrument and reagent problem can be excluded as a root cause. The customer has not complained of any additional issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01812 |
| MDR Report Key | 6817793 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-24 |
| Date of Event | 2017-07-01 |
| Date Mfgr Received | 2017-08-07 |
| Date Added to Maude | 2017-08-24 |
| 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CIT |
| Date Received | 2017-08-24 |
| Model Number | C702 |
| Catalog Number | ASKU |
| 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-24 |
| Model Number | C702 |
| Catalog Number | ASKU |
| 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 | 2017-08-24 |