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 2017-03-17 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[70183848]
Unique device identifier (udi)#: asku. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[70183849]
The customer received questionable etoh2 ethanol gen. 2 (etoh) results for one patient sample.? The original result was 0. 03 per mille with a data flag. The sample was repeated with a result of 0. 16 per mille and was reported outside the laboratory to the physician.? The physician questioned the result because it did not match the patient's clinical status. The patient was "drunk. " a new sample was drawn and tested on a different analyzer with a result of 3. 17 per mille. The original sample was repeated on this analyzer with results of 3. 14 per mille and 3. 11 per mille. No treatment was given based on the erroneous result. There was no allegation of an adverse event.? The etoh reagent lot number and expiration date were requested but not provided.? Calibration and qc were acceptable prior to and on the day of the event. It was noted that the customer used 13mm sample tubes without a recommended rack adapter. A specific root cause could not be identified. There was no indication of a general issue with the system or the reagent. Possible root causes for this event may be related to pre-analytics. These include foam and bubbles on top of the sample, resulting in zero pipetting; or inadequate level detection due to the tube not being upright in the rack. Additional information was requested for investigation but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00576 |
| MDR Report Key | 6412605 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-17 |
| Date of Report | 2017-03-17 |
| Date of Event | 2017-02-13 |
| Date Mfgr Received | 2017-03-01 |
| Date Added to Maude | 2017-03-17 |
| 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 | DIC |
| Date Received | 2017-03-17 |
| Model Number | C501 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-03-17 |
| Model Number | C501 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-03-17 |