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 2017-09-14 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[87231003]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[87231004]
The customer questioned low direct bilirubin (bild2) and bilt3 bilirubin total gen. 3 (bilt3) results for 1 patient sample tested on a cobas 6000 c (501) module. Based on the data provided, the total bilirubin results were erroneous. The erroneous results were not reported outside of the laboratory. The initial bilt3 result from a hitachi cup was 16. 8 (unit of measure not provided). The repeat result was 235. There was no allegation that an adverse event occurred. The bilt3 reagent lot number and expiration date were not provided. The customer cleans the sample probe every day with alcohol. A specific root cause was not identified. The system has run with no further deviations since this one occurrence. Based on the reaction curve provided, sample was missing from the reaction. Bilt3 is sensitive to disturbances due to a partly clogged sample probe. A review of the customer? S service history did not suggest any pre-analytical issues. A possible root cause may be that a prior sample was not centrifuged long enough or a sample that tends to clot after centrifugation caused a micro clot, but this cannot be confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01973 |
| MDR Report Key | 6864147 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2017-08-23 |
| Date Added to Maude | 2017-09-14 |
| 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 |
| 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 | MQM |
| Date Received | 2017-09-14 |
| 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 | 2017-09-14 |