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 2017-06-05 for COBAS 8000 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[76833885]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76833886]
The customer received a questionable high etoh2 ethanol gen. 2 result for one patient sample. The initial result was 46 mmol/l and was reported to the er. The husband of the patient questioned the result and a new sample was drawn. The result from the new sample was -2 mmol/l with a data flag. The original sample was repeated on the original analyzer and another analyzer. The result from both analyzers was 0 mmol/l with a data flag. The patient was not adversely affected. The reagent lot number was 223279. The expiration date was requested but was not provided. The qc results were within specification before and after the erroneous result was generated. The field service representative found there was a misadjusted gear pump. He replaced the sample probe, backflushed the reagent and sample probe, increased the gear pump pressure, and checked the rinse mechanism volumes and washstation water rinse pressure. He ran performance testing with all results negative. The customer ran qc with results within range.
Patient Sequence No: 1, Text Type: D, B5
[86904433]
Further investigation could exclude a general issue with reagent as calibration was acceptable and both control levels were well within specifications. The reaction kinetics were found to be normal. Based on the field service representative's findings, the most probable cause of the issue was a sporadic contamination or carryover effect due to inefficient washing. The instrument is now working within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01155 |
| MDR Report Key | 6611599 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-05 |
| Date of Report | 2017-06-13 |
| Date of Event | 2017-05-21 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-06-05 |
| 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 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DIC |
| Date Received | 2017-06-05 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-05 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 | 2017-06-05 |