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 2017-08-04 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[82067370]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[82067371]
The customer complained of an erroneous low result for 1 patient sample tested for etoh2 ethanol gen. 2 (etoh2) on a cobas 6000 c (501) module. The erroneous result was reported outside of the laboratory. The initial etoh2 result was 0. 017 g/l. This result was reported outside of the laboratory where the result was not believed as the patient was drunk. The sample was repeated and the result was 3. 20 g/l. There was no allegation that an adverse event occurred. The patient was not treated based on the erroneous low result. The etoh2 reagent lot number was 244284. The expiration date was not provided. A review of the alarm trace shows an abnormal probe sucking alarm that occurred later the same day after the low result and frequent sample duplication errors. A specific root cause was not identified. Additional information was requested for investigation but was not provided. Since the customer? S calibration and quality control results were acceptable, both a general reagent issue and instrument issue can be excluded. Possible explanations for the low result may be sporadic contamination of the sample probe resulting in no sample being pipetted or there may have been foam or bubbles on top of the sample. The abnormal probe sucking alarm suggests a clot in a sample. The most likely root cause of the issue is related to pre-analytics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01596 |
| MDR Report Key | 6766755 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-04 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-07-14 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-08-04 |
| 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 | 2017-08-04 |
| 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 | 2017-08-04 |
| 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 | 2017-08-04 |