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 2017-08-17 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[83255590]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83255632]
The customer alleged erroneous results for 1 patient tested for d bili direct bilirubin (d bili) on a cobas 6000 c (501) module. One patient sample was being tested for multiple chemistry tests and total psa. The total psa test was processed first and then the sample was sent to the c501 module for the other tests. When the tests were completed and were sent to the host, the tech noticed that the d bili result in the laboratory information system (lis) was 5. 22 mg/dl. The tech did not accept this result and reviewed what the c501 module tested originally. The initial d bili result was 0. 20 mg/dl with a data flag and the sample repeated with the same result. The result of 0. 20 mg/dl with a data flag was believed to be the correct result and was reported outside of the laboratory. The result of 5. 22 mg/dl could not be located in the data review screen but, according to the log from the lis, this result was produced by the c501 module. Attempts were made to determine when this result was produced, however, due to the customer? S settings, this could not be confirmed. The result of 5. 22 mg/dl could have been overwritten by the next result for d bili. Another potential explanation for the 5. 22 mg/dl result was that the customer used an unspun whole blood sample that was tested for d bili, however, the customer states this did not occur. No adverse event occurred. The d bili reagent lot number was 21901301 with an expiration date of 09/30/2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01719 |
| MDR Report Key | 6799905 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-17 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-07-27 |
| Date Added to Maude | 2017-08-17 |
| 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 | 2017-08-17 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-17 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 | 2017-08-17 |