MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG; IH-CARD AHG ANTI-IGG 288 CARDS

Catalog Number	813422100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that a specimen was tested as a rh(d) positive on ih-1000 using the ih card ahg anti-igg.But when the specimen was re-tested manually, the result was b rh(d) positive.The customer repeated the testing on ih-1000 and the result came back as b rh(d) positive.The information provided by the customer and the complained ih-card do not match.The customer reported an incorrect abo blood group typing, but filed his complaint for an ih-card ahg anti-igg which is not suited for abo blood group typing, but for antibody screening and identification.Therefore our quality control laboratory required the correct product and lot information, but the customer has so far not come forward with this information.Due to the lack of information a testing of the retention sample has not yet been performed.And because of the missing lot information a review of the batch record documentation of the supposedly defective product was not possible.
Event or Problem Description
The customer reported that a specimen (hereinafter referred to as sample a) was tested as a rh (d) positive on ih-1000.But when the specimen was retested manually, the result was b rh (d) positive.The customer repeated the testing on ih-1000 and the result came back as b rh (d) positive.The customer specified that there were only two samples on the same rack which were processed directly one after the other.One of these samples was a rh (d) positive (hereinafter referred as sample b).The information initially provided by the customer and the complained ih-card did not fit together.The customer reported an incorrect abo blood group typing, but filed his complaint for an ih-card ahg anti-igg (lot 8825050) which is not suited for abo blood group typing, but for antibody screening and identification.The affected ih-card abo/d (dvi-)+rev a1,b art.-no.813112100 lot no.8817120 (expiry date 2019-08-24) was only noted when the trace file analysis was performed.The customer did not provided any patient sample but only some screenshots of the results of both samples tested.It was noted that at the first testing the ih-1000 with the serial number 5100022 was used.First sample loaded on the rack was sample b with the expected blood group a rh (d) positive.Thereafter two samples with the same barcode (referring as sample a) were loaded.In case of the presence of two samples with the same barcode the ih-1000 as a safety system and displays the warning message "two sample tubes with same barcode identified" on the main-screen and only the first sample tube identified will be tested.In this case, two results were obtained for the three (3) samples on the same rack.The results were a rh (d) positive.Therefore, we highly suspect that the complaint was more linked an user error by incorrect labeling of the tube sample which could explain the difference on the blood group results.For further investigations, we requested the information if it is accepted and possible at the customer site to duplicate the barcode sample.Unfortunately, the customer has never replied to this and other questions.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.Based on the information available we assume that a mixing of samples occurred due to a possible duplication of the same barcode sample for two different patient samples.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG
• Common Device Name: IH-CARD AHG ANTI-IGG 288 CARDS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8110185
• Report Number: 9610824-2018-00081
• Device Sequence Number: 17068271
• Product Code: QHS
• UDI-Device Identifier: 07611969964857
• UDI-Public: (01)07611969964857
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: 125098
• 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): 01/08/2021

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: 08/19/2019
• Device Catalogue Number: 813422100
• Device Lot Number: 8825050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/08/2021
• 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: HI-CARD ABO/D (DVI-)+REV A1,B, LOT 8817120.; IH-1000, #5100013.; IH-1000, #5100013.