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	12/22/2016
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 mistyping of two donor samples and one patient sample on tango optimo.The two donor units were labelled as a pos, but tango optimo called one sample o neg and the second one a neg.The patient sample was b pos, but the instrument typed it as b neg.The customer suspected the bromelin to be the cause for the false negative results.The customer assumed that the bromelin solution was filled in bottles that might not have been cleaned as thoroughly as usual.The customer reported that the issue was resolved after she had cleaned the bromelin bottles and made fresh bromelin solutions.The customer returned the supposedly defective product, but not the donor respectively patient samples which had caused false negative test results.Our quality control laboratory prepared the ready to use solution of the provided bromelin and tested it on tango optimo.Different donor samples were tested on the erytype configurations erytype s abd+rev.A1, b, erytype rhd confirm, erytype s abo confirm and erytype s rh+k type.All positive and negative reactions were correct.We did not observe any false negative reactions.Testing by our quality control laboratory confirmed that the allegedly defective lot of bromelin for erytype functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• 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: 6252955
• Report Number: 9610824-2016-00103
• Device Sequence Number: 19075242
• Product Code: KSZ
• UDI-Device Identifier: 07611969951307
• UDI-Public: 07611969951307
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/16/2017

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: 02/20/2017
• Device Catalogue Number: 806210100
• Device Lot Number: 8634100-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TANGO OPTIMO, # 9142400490