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 2017-08-07 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[82722879]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[82722880]
The customer obtained questionable high test results for three patient samples using the trigl triglycerides (trigl) assay on the cobas 6000 c (501) module. Result data was provided for one patient sample. The initial result was released outside of the laboratory to the doctor. All results are in units of mg/dl. The initial result was 220; the repeat result on a different module was 118. There was no allegation that an adverse event occurred. The trigl reagent lot number is 22259201 with an expiration date of 02/28/2018. The customer changed the cuvettes and the photometer lamp "last week" and changes them regularly. Calibration and quality controls were acceptable; therefore, a general reagent issue could be excluded. The reaction monitor data was abnormal for both results. The alarm log indicated an abnormal probe sucking alarm which was possibly related to the initial result. The customer performed a precision check on (b)(6) 2017. The cell rinse functionality for trigl was acceptable. The field service representative (fsr) stated that the customer has had a few pre-analytical issues. Some of the samples come from external clinics and sample quality is poor. The fsr adjusted up the gear pump pressure which was very low; performed a cell detergent prime; and changed the teflon tips of the washing station. He confirmed that all necessary special wash programs were installed. He checked the detergent consumption and water quality which were acceptable. He took water samples and sent them for microbial analysis. The customer has not had further issues since the service activities. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01625 |
| MDR Report Key | 6770489 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-07 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2017-07-17 |
| Date Added to Maude | 2017-08-07 |
| 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 | 2017-08-07 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-08-07 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-08-07 |