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 2017-09-21 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[89242136]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89242137]
The customer complained of discrepant ureal urea/bun (bun) for one patient sample. The initial sample was aliquoted by a modular pre-analytics (mpa) and bun testing was performed with an initial result of 129 mg/dl accompanied with a data flag. The sample was automatically rerun diluted by the analyzer and a result of 130 mg/dl was obtained. The primary collection tube was then run on another cobas 8000 c 702 module (c702) and a bun result of 8 mg/dl was obtained. The result from the other c702 was deemed to be correct. The discrepant results were not reported outside of the laboratory. There was no adverse event. The bun reagent lot was 19683601 with an expiration date of 31-aug-2017. This medwatch will cover the c702 module. Refer to medwatch (b)(4) for information on the mpa. The field engineering specialist was unable to find a cause for the malfunction. He performed system operational checks all which passed. He deemed the system operational. A historical query for this site was performed and no new or past escalated complaints of this nature on any like instruments were found for the past 12 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02028 |
| MDR Report Key | 6882060 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-21 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-08-28 |
| Date Added to Maude | 2017-09-21 |
| 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDQ |
| Date Received | 2017-09-21 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 | 2017-09-21 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 | 2017-09-21 |