MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BROMELIN FOR ERYTYPE, 10 ML

Catalog Number	806210100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported a false positive results for anti-d on two different tango optimo on site when using bromelin for erytype.The customer suspected that the bromelin for erytype would not work for full 24 hours after preparing the working solution.The customer observed "weird looking results" in the d- wells when using solution that was prepared approximately 22 hours ago.The customer did not send in the allegedly defective for investigational testing.Therefore our quality control laboratory tested their retained sample of the supposedly defective lot bromelin for erytype and also a reference lot.Both reagents were tested when freshly prepared and a second time after 22 hours "on board".Erytype s abd+rev.A1b #8646110 was used for the testing which is the same lot that was used by the customer.All positive and negative reactions were correct.We did not observe any false positive reaction.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot bromelin for erytype.Both affected tango optimo were checked by our field service engineer.No indication for an instrument malfunction could be identified, both instruments were confirmed to operate within specification.The customer assumes improper mixing of reagents by a new employee.

• Brand Name: BROMELIN FOR ERYTYPE, 10 ML
• Common Device Name: BROMELIN FOR ERYTYPE
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6787396
• Report Number: 9610824-2017-00053
• Device Sequence Number: 992653
• Product Code: KSZ
• UDI-Device Identifier: 07611969965755
• UDI-Public: 07611969965755
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BK040070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2017
• Device Catalogue Number: 806210100
• Device Lot Number: 8712070-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1