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 2017-10-18 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[90652089]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[90652090]
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 0. 04 g/l and this value was reported outside of the laboratory. Since the patient appeared to be drunk and smelled of alcohol, the sample was repeated with a result of 3. 22 g/l. The heparin tube of the sample was repeated, resulting as 3. 16 g/l. The serum tube of the sample was also repeated, resulting as 3. 20 g/l. No adverse events were alleged to have occurred with the patient. The etoh reagent lot number was 259608. The reagent expiration date was asked for, but not provided. The field service engineer performed maintenance and decontaminated the analyzer. He ran photometer checks before and after maintenance. Precision testing was also performed. Calibration signals are consistent. Quality controls are mainly within range between 01-jul-2017 and 04-oct-2017. As calibration and controls are acceptable, a general issue with the reagent or instrument can be excluded. Upon review of the alarm trace, frequent abnormal sample aspiration alarms occurred between (b)(6) 2017. These alarms suggest contamination of the probe, therefore a pre-analytic sample handling issue is most likely. Photometer checks were within specifications. Precision of the glucose parameter was found to be higher than expected and suggests possible sample pipetting issues. The most possible causes of the observed issue are foam on top of the sample, sample quality, or a clotted/contaminated sample probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02362 |
| MDR Report Key | 6958585 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-18 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-10-04 |
| Date Added to Maude | 2017-10-18 |
| 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 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DIC |
| Date Received | 2017-10-18 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-18 |