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 2017-10-11 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[90311171]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90311172]
On (b)(6) 2017, the customer replaced the probe on the cobas 6000 c (501) module - c501. On (b)(6) 2017, the customer stated that they had been having ongoing calibration errors with albt2 tina-quant albumin gen. 2 (malb) on the c501 starting on (b)(6) 2017. The customer tried changing the calibrator lot and using fresh saline, but the issue persisted. The customer loaded a new reagent cassette and controls tested on this cassette were within range. Calibrator set points were checked and these were correct. The customer later believed the issue to be related to the sample probe and replaced it. The malb test was calibrated. Quality controls were run without any issues. The customer repeated some patient samples and found that 7 of these had questionable initial results. Of these 7 samples, six had erroneous initial results that were reported outside of the laboratory. All samples were repeated on (b)(6) 2017 and these repeat results were believed to be correct. The first sample initially resulted as 48. 6 mg/l on (b)(6) 2017 and repeated as 19. 1 mg/l on(b)(6) 2017. The sample had the following additional repeat values: 10. 3 mg/l and 8. 6 mg/l on (b)(6) 2017 and 17. 2 mg/l on (b)(6) 2017. The second sample initially resulted as 42. 1 mg/l on (b)(6) 2017 and repeated as 8. 9 mg/l on (b)(6) 2017. The sample had the following additional repeat values: 24. 8 mg/l and 18. 7 mg/l on (b)(6) 2017 and 16. 9 mg/l on (b)(6) 2017. The third sample initially resulted as 86. 1 mg/l on (b)(6) 2017 and repeated as 15. 3 mg/l on(b)(6) 2017. The fourth sample initially resulted as 132 mg/l on (b)(6) 2017 and repeated as 15. 4 mg/l on (b)(6) 2017. The fifth sample initially resulted as 64. 1 mg/l on (b)(6) 2017 and repeated as 20. 9 mg/l on (b)(6) 2017. The sixth sample initially resulted as 48. 0 mg/l on 15-sep-2017 and repeated as 6. 1 mg/l on (b)(6) 2017. One of the 7 repeated patient samples had the following malb values, but the customer could not confirm which of the 7 patients these values correspond to: 6. 1 mg/l on (b)(6) 2017, 13. 7 mg/l and 7. 3 mg/l on (b)(6) 2017, and 32. 3 mg/l on (b)(6) 2017. No adverse events were alleged to have occurred with the patients. The malb reagent lot number was 24167501. The reagent expiration date was asked for, but not provided. The customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02266 |
| MDR Report Key | 6940395 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-11 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-09-20 |
| Date Added to Maude | 2017-10-11 |
| 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 | 0 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJW |
| Date Received | 2017-10-11 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |