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 2017-06-20 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[78190282]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78190283]
The customer received questionable results for four patient samples over several days. Data was only provided for a questionable total bilirubin result for one patient sample. The initial result from a microcup was 0. 26 mg/dl. The repeat result from the microcup was 1. 38 mg/dl. This result was reported outside the laboratory and was questioned by the doctor. A new sample was collected from the patient and tested on another cobas 6000 c (501) module in a hitachi sample cup with a result of 16 mg/dl. The patient was not adversely affected. The reagent lot number and expiration date were requested but were not provided. The customer performed correlations between the two instruments using the sample cups and they correlated well. The customer tested additional patient samples and qc material for troubleshooting and received incorrect results when the samples were tested in the microcups. The customer checked the sample probe and it was okay. The field service representative found there was an issue with the probe. He replaced and adjusted the sample probe, cleaned and lubricated the rack track, and replaced the sample syringe seals. He ran mechanism checks and diagnostic checks with results within specifications. The customer performed calibration and controls with results within specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01279 |
| MDR Report Key | 6652924 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-20 |
| Date of Report | 2017-06-20 |
| Date of Event | 2017-06-03 |
| Date Mfgr Received | 2017-06-06 |
| Date Added to Maude | 2017-06-20 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MQM |
| Date Received | 2017-06-20 |
| 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 | 2017-06-20 |
| 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 | 2017-06-20 |