MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-CELL I-II-III

Catalog Number	814030100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false negative reactions of two patient samples with ih-cell i-ii-iii on the ih-500 instrument.The customer stated that sample #(b)(6) (blood group o) contained the antibodies anti-c and anti-e and sample #(b)(6) (blood group a) anti-c and anti-jkb.The missed antibodies were identified by the american red cross using the tube method with the enhancement medium peg (polyethylene glycol).The customer did neither provide a sample of the allegedly defective product ih-cell i-ii-iii for investigational testing or the patient samples that had caused the false negative test results.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot.The investigation is still ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Instrument data of the affected ih-500 instrument were collected by one of our field service engineers.Analysis of the received databases for any issue relevant anomalies is still ongoing.
Additional Manufacturer Narrative
This is our initial report on this incident.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported false negative reactions of two patient samples with ih-cell i-ii-iii on the ih-500 instrument.The customer stated that sample #(b)(6) (blood group o) contained the antibodies anti-c and anti-e and sample #(b)(6) (blood group a) anti-c and anti-jkb.The customer was concerned that not all little c reactive cells on the bio-rad antibody detection and identification panels reacted with sample (b)(6).They are also concerned that not all jkb reactive cells on the bio-rad antibody detection and identification panels reacted with sample (b)(6).The missed antibodies were identified by the american red cross using the tube method with the enhancement medium peg (polyethylene glycol).The customer did neither provide a sample of the allegedly defective product ih-cell i-ii-iii for investigational testing nor the patient samples that had caused the false negative test results.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot on the ih-500.Our quality control laboratory used three known antibodies (anti-c, anti-e and anti-jkb ) and donor samples for testing.All positive and negative reactions were correct.We did not observe any false negative reaction.Furthermore, the quality control laboratory checked the antigenicity of the reagent red blood cells ih-cell i-ii-iii.The verification was performed manually by means of titer determination.Geometric dilution series (twofold serial dilutions) with the antibodies anti-c, anti-e and anti-jkb were used for this purpose.We did not observe any weakening of antigenicity.This was the case for anti-c, anti-e, and anti-jkb antigens.Data files of the affected ih-500 were analyzed for anomalies.The data files only contained the results of ih-panel 11, but not the ones for the screening cells ih-cell i-ii-iii.The customer had only provided a screen shot of patient sample (b)(6) with ih-cell i-ii-iii.The image showed positive reactions with ih-cell 1 and 2, but a negative reaction with cell 3.Due to the antibodies anti-c and anti-jkb all three screening cells were supposed to show a positive reaction.The customer did not provide a screenshot of sample (b)(6) with ih-cell i-ii-iii.An investigation of the instrument was therefore not possible.Based on the investigation the complaint was classified as undetermined: the customer did not provide the complaint sample or the patient samples that caused the false negatives.The retention sample reacted as expected.A general issue with the reagent red blood cells ih-cell i-ii-iii could be ruled out.Comparative tests demonstrated that the antigenicity of the claimed ih-cell i-ii-iii was not weakened.Due to the biological origin of the reagent red blood cells a slight variability of the antigenicity is explainable, acceptable and within the range.Due to the lack of the data files in question an investigation of the instrument was not possible.

• Brand Name: REAGENT RED BLOOD CELLS IH-CELL I-II-III
• Common Device Name: IH-CELL I-II-III
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich 63303 ; 0049610331
• MDR Report Key: 16893599
• Report Number: 9610824-2023-00018
• Device Sequence Number: 6141740
• Product Code: QHT
• UDI-Device Identifier: 07611969952267
• UDI-Public: (01)07611969952267(17)230508(10)9310011
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: 125208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 05/08/2023
• Device Catalogue Number: 814030100
• Device Lot Number: 9310011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IH-500, SN (B)(6); IH-500, SN (B)(6)
• Patient Sex: Unknown