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 2017-09-21 for COBAS 8000 C 702 MODULE C702 manufactured by Roche Diagnostics.
[89313719]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[89313720]
The customer had an ongoing issue with low ureal urea/bun results that upon repeat testing on another analyzer would be normal. Of the data provided for seven patient samples, only the results for two patient samples were discrepant. Patient 1 initial result was 0. 54 mmol/l and the repeat result was 15. 06 mmol/l. Patient 2 on (b)(6) 2017, the initial result was 2. 25 mmol/land the repeat result was 25. 80 mmol/l. The initial results were reported outside the laboratory and were later amended. There was no allegation of an adverse event. No other assays were affected. The reagent lot in use for patient 1 was 181348 and the reagent lot in use for patient 2 was 212533. The expiration dates were requested but were not provided. All of the sample probes and rinse tubings were replaced. A precision check and accumulative qc performance was acceptable. All rinse water levels, vacuums, sample and reagent probe alignments, and sample quality were checked and found to be acceptable. It was suspected the issue was due to crystals from the detergent used for cleaning the system. The field service representative performed preventive maintenance and found a few crystals around the ultrasonic mixer (usm).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02030 |
| MDR Report Key | 6882143 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-21 |
| Date of Report | 2018-02-19 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-08-30 |
| 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 | 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-21 |
| Model Number | C702 |
| 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 | 2017-09-21 |