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	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported about unexpected positive results of known rh d negative samples by erytype s abd+rev a1,b on his both tango optimo instruments.The customer was suspecting that the bromelin for erytype+erytype s (lot # 8701110-00) could be the cause for the false positive results and returned the supposedly defective product for investigational testing.But on date of receipt ((b)(6)2017) the complaint material was already expired (exp.: 07/04/2017).Our quality control is planning further testing, the investigations are ongoing.Both affected tango optimo instruments were inspected by one of our field service engineers with no indication for an instrument malfunction.The instruments were confirmed to operate within specifications.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a discrepancy when typing on two tango optimo instruments.Rh negative samples were being read as positive.The customer suspected the bromelin for erytype to be the cause for the false positive results.The customer sent back the allegedly defective product bromelin for erytype for investigational testing but at the time the allegedly defective product arrived at bmd it was already expired, was contaminated and even mouldy.Therefore our quality control laboratoy tested their retained sample bromelin for erytype, #8701110-00.The erytype s abd+rev.A1b #8646110, that was used by the customer, was also used in this test.12 samples were tested and all reactions were as expected.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 of bromelin for erytype.Both affected tango optimo were inspected by our field service engineer with no indication for a malfunction.Both instruments are working within specifications.

• 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: 6747023
• Report Number: 9610824-2017-00049
• Device Sequence Number: 881429
• 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,Followup
• 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: 07/04/2017
• Device Catalogue Number: 806210100
• Device Lot Number: 8701110-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement 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