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 2017-09-11 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[86846283]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86846284]
The customer stated that they received an erroneous result for one patient sample tested for bilt3 bilirubin total gen. 3 (tbil) on a cobas 6000 c (501) module - c501. It was asked, but it is not known if the erroneous result was reported outside of the laboratory. The sample initially resulted as 17. 499 mg/dl accompanied by a data flag when tested on the c501 analyzer. The sample was repeated on a cobas integra 400 (i400) analyzer, resulting as 6. 13 mg/dl accompanied by a data flag. The 6. 13 mg/dl value matched the previous report and diagnosis of the patient. No adverse events were alleged to have occurred with the patient. The tbil reagent lot number was 20143601, with an expiration date of (b)(6) 2018. Upon review of the reaction monitor for the 17. 499 mg/dl value, no issues were seen. Calibrations performed on both c501 and i400 analyzers were ok. Quality control recoveries on both analyzers were ok. No issues were seen upon review of the c501 analyzer alarm trace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01938 |
| MDR Report Key | 6854566 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-11 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-08-17 |
| Date Mfgr Received | 2017-08-22 |
| Date Added to Maude | 2017-09-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2017-09-11 |
| 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 | 2017-09-11 |
| 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 | 2017-09-11 |