MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT IH-CARD ABD(DVI+)-CONF; IH-CARD ABD(DVI+)-CONF; 48 CARDS

Catalog Number	813191100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our intial report on this incident.
Event or Problem Description
The customer reported false positive results ih-card abd (dvi+)-conf on ih-500.The customer also reported some technical issues and a pipettor error message.She did not provide a date of event.The customer returned neither the supposedly defective lot for investigational testing nor the samples that caused false positive test results.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples and controls on ih-500.All positive and negative reactions were correct.We did not observe any false positive reactions.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The investigation of the instrument data is still ongoing.
Event or Problem Description
The customer reported false positive results ih-card abd (dvi+)-conf on ih-500.The customer also reported some technical issues and a pipettor error message.She did not provide a date of event.The customer returned neither the supposedly defective lot for investigational testing nor the samples that caused false positive test results.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples and controls on ih-500.All positive and negative reactions were correct.We did not observe any false positive reactions.The donor samples showed clearly negative results, evaluated both visually and by the software of the instrument.Furthermore, the retention sample was visually checked, and all acceptance criteria were met.The specifications were: visible supernatant, homogeneous gel, intact sealing, no splashes in the reaction chamber.The customer states that after spinning cards, they no longer had any false positives.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Regarding the affected ih-500: due to missing information like card id and date and time when the false positive result appeared it was not possible to analyze the case in detail.The received snapshot files did not show a (general) problem which could have led to the mentioned issue.According to an e-mail, the weekly maintenance was performed the last time 2 weeks before the issue started.A missing weekly "weekly maintenance" may lead to false results.We would like to point out that the weekly maintenance should be done within the required timeframe.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ABD(DVI+)-CONF
• Common Device Name: IH-CARD ABD(DVI+)-CONF; 48 CARDS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 11214596
• Report Number: 9610824-2020-00098
• Device Sequence Number: 2967431
• Product Code: QHR
• UDI-Device Identifier: 07611969952137
• UDI-Public: (01)07611969952137(17)210928(10)8022070
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 125534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 09/28/2021
• Device Catalogue Number: 813191100
• Device Lot Number: 8022070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2020
• Supplement Date Received by Manufacturer: 12/27/2020
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 02/25/2021
• 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: IH CARD ABD/D(DVI-)+REV A1,B, LOT 8035010; IH CARD ABD/D(DVI-)+REV A1,B, LOT 8035010; IH-500, SN (B)(6); IH-500, SN (B)(6)