MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBP ALBUMIN BCP; BROMCRESOL PURPLE DYE-BINDING, ALBUMIN

Model Number	ALB BCP
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For two events the investigations are ongoing.The follow up/corrective actions: none listed.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 2 malfunction events.Erroneous low results were generated by the cobas 6000 c (501) module.The events involved a total of 2 patients with low results for albp albumin bcp.The patients' ages ranged were "newborns".
Additional Manufacturer Narrative
For both events: the investigation tested retention albumin reagent lots with precicontrol solution on a c 501 module.All results were comparable to one another.The investigation also used 10 blood samples from internal donors.From each donor, a venous sample and a capillary sample was obtained and tested with retention albumin reagent on a c501 module.A difference in results between venous and capillary samples was not observed.The results were comparable to one another.The customer's allegation could not be confirmed.A general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ALBP ALBUMIN BCP
• Common Device Name: BROMCRESOL PURPLE DYE-BINDING, ALBUMIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8551515
• Report Number: 1823260-2019-90096
• Device Sequence Number: 13849818
• Product Code: CJW
• UDI-Device Identifier: 04015630927562
• UDI-Public: 4015630927562
• Combination Product (Y/N): N
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: ALB BCP
• Device Lot Number: 382380, 350769
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 10/21/2019
• Patient Sequence Number: 1