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 2017-08-08 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[83307249]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83307250]
The customer received questionable results for trigl triglycerides, chol2 cholesterol gen. 2, and ldl_c ldl-cholesterol plus 3rd generation. Of the data provided, only the results for triglycerides and cholesterol were discrepant. The initial triglyceride result was 427 mg/dl and the repeat result was 150 mg/dl. The repeat result on another analyzer was 149 mg/dl. The initial cholesterol result was 329 mg/dl and the repeat result was 230 mg/dl. The repeat result on another analyzer was 215 mg/dl. None of the erroneous results were reported outside the laboratory. There was no allegation of an adverse event. The triglyceride reagent lot number was 22259201 with an expiration date of 02/28/2018. The cholesterol reagent lot number was 18399500 with an expiration date of 10/31/2017. The service personnel found the metal plate had scratched the edge of the cuvettes and generated a white powder that contaminated the cuvettes as they rotated. He adjusted the position of the metal plate and performed precision testing. The provided calibration and qc data was acceptable and ruled out general reagent issues. It was noted the calibrator had expired prior to its use. The investigation could not determine a specific root cause. The issue appeared to be related to a customer handling issue due to the use of the expired calibrator material, insufficient maintenance actions, and improper centrifugation conditions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01642 |
| MDR Report Key | 6773579 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-08 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-07-21 |
| Date Mfgr Received | 2017-07-21 |
| Date Added to Maude | 2017-08-08 |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JGY |
| Date Received | 2017-08-08 |
| Model Number | C501 |
| Catalog Number | ASKU |
| 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 | 2017-08-08 |
| Model Number | C501 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-08 |