MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-23 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[78291570]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78291571]
The customer stated that they were having problems with the albt2 tina-quant albumin gen. 2 (malb) assay on the cobas 6000 c (501) module - c501 from (b)(6) 2017. The customer stated that there were issues calibrating the assay and there have been random questionably high results for an unspecified number of patient samples. Repeating these patient samples would yield normal results. The customer stopped running the assay and sought alternate means of testing. The customer stated that some questionable patient results were reported outside of the laboratory. The customer provided an example of one patient sample that had an erroneous initial result that was reported outside of the laboratory. The initial malb result for the urine sample was 12. 9 mg/dl. The sample was repeated, resulting as < 1. 2 mg/dl with a data flag.. The repeat value was believed to be correct. The patient was not adversely affected. The malb reagent lot number was 21974301, with an expiration date of 11/30/2018. The field service engineer determined that the gear pump pressure and the cuvette water level were slightly below range. He adjusted the gear pump and cuvette water level into range. He verified adjustments and performed mechanism checks to ensure proper operation. He also replaced vacuum diaphragms due to small cracks. The customer ran quality controls.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01319 |
| MDR Report Key | 6663081 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-23 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-06-08 |
| Date Mfgr Received | 2017-06-09 |
| Date Added to Maude | 2017-06-23 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJW |
| Date Received | 2017-06-23 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-23 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 | 2017-06-23 |