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 2017-07-10 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[80053297]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80053298]
The customer stated that between (b)(6) 2017, they had issues with quality controls randomly being outside of range for albt2 tina-quant albumin gen. 2 (malb) on the cobas 6000 c (501) module - c501. The controls were repeated and then recovered okay. On (b)(6) 2017, the customer noticed that they also were having issues with discrepant patient results. The customer started to repeat all patient samples to ensure the instrument was generating correct results the customer provided data for a total of 13 samples that had questionable malb result. Of these, three had erroneous results that were reported outside of the laboratory. The first sample initially resulted as 28. 5 mg/l. The sample was repeated twice, resulting as 11. 3 mg/l and 8. 0 mg/l. The second sample initially resulted as 25. 3 mg/l. The sample was repeated twice, resulting as 6. 3 mg/l and < 3 mg/l. The third sample initially resulted as 107. 9 mg/l on (b)(6) 2017. The sample was repeated twice, resulting as 24. 4 mg/l and 30. 4 mg/l. No adverse events were alleged to have occurred with the patients. The malb reagent lot number was 219743. The reagent expiration date was asked for, but not provided. Precision studies were performed on the analyzer and precision for triglycerides was outside of specifications. The field service engineer found that there was an issue with the customer's water system. The carbon levels of the water were high.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01414 |
| MDR Report Key | 6696399 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-10 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJW |
| Date Received | 2017-07-10 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-10 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| 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 | 2017-07-10 |