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 2017-06-09 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[77651023]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77651024]
The customer stated that they received an erroneous result for one patient sample tested for etoh2 ethanol gen. 2 (etoh) on a cobas 6000 c (501) module - c501. The sample initially resulted as 26. 2 mg/dl and this value was reported outside of the laboratory. The doctor questioned the result. The sample was repeated, resulting as < 10 mg/dl accompanied by a data flag. The repeat result was believed to be correct. The patient was not adversely affected. The etoh reagent lot number was 20806301, with an expiration date of 07/31/2017. The field service engineer determined that the sample probe was not springing into home position properly. He adjusted the sample probe. He checked rinsing and drying. He performed precision studies and these were within specifications. The system was operating within specifications.
Patient Sequence No: 1, Text Type: D, B5
[118338553]
Upon review of calibration data, no calibration issues were seen and calibration signals were consistent. As calibration is acceptable and quality controls before and after the event are acceptable, a reagent or instrument issue can be excluded. Possible root causes include sample mismatch, sample carryover due to contamination of the sample probe, and contamination in the water bath.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01199 |
| MDR Report Key | 6630906 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-09 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-05-26 |
| Date Added to Maude | 2017-06-09 |
| 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 | 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 | DIC |
| Date Received | 2017-06-09 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-09 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-06-09 |