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 2017-09-06 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[85016534]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[85016535]
The customer complained of questionable results for ureal urea/bun. The customer provided the data for 3 patients, of which only one was a reportable malfunction. The initial ureal urea/bn result was 19 mg/dl. The repeat result was 64 mg/dl. The repeat result is deemed to be correct. The initial result was reported outside of the laboratory and a corrected report had to be issued. There was no allegation of any adverse events. The ureal urea/bun reagent lot number is 19683601 with and expiration date of 31-aug-2017. The sample was processed by a modular pre-analytics system. The field engineering specialist was unable to determine a cause for the malfunction. He checked the overall system operation and no problems were found. He adjusted the gear pump pressure and cleaned the cell rinse nozzle retainers. Calibration, qc, and a precision run of bun and cholesterol was run all which passed. The customer has had no similar events in the previous 12 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01911 |
| MDR Report Key | 6846083 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-06 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-08-16 |
| Date Mfgr Received | 2017-08-18 |
| Date Added to Maude | 2017-09-06 |
| 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDQ |
| Date Received | 2017-09-06 |
| 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 | 2017-09-06 |
| 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 | 2017-09-06 |