MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-CELL POOL; IH-CELL POOL; 10 ML

Catalog Number	814060100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that one result was called negative by the ih-1000 sn (b)(4) when using ih-cell pool, although it looked visually like a +/- reaction.The customer stated that the pellet looked uneven.The sample was also tested on the ih-1000 sn (b)(4) and yielded a 1+ positive reaction.The customer did not provide the complaint sample for investigational testing but announced to ship the affected patient sample.Our quality control laboratory is still waiting for the patient sample.In the meantime, our quality control laboratory team tested their retention sample of the supposedly defective lot ih-cell pool on ih-1000.The testing was performed with several weak reaction antibodies and controls.All positive and negative reactions were correct.They were correctly evaluated.We did not observe any false negative reaction.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 affected ih-1000 instrument is still ongoing.
Event or Problem Description
The customer reported that one test result was called negative by the ih-1000 sn (b)(6), although it looked visually as +/-.The customer stated that the pellet looked uneven.The sample was also tested on the ih-1000 sn (b)(6) and yielded a 1+ positive reaction.The customer used ih-cell pool for his testing.The customer did not provide the complaint sample ih-cell pool fr investigational testing but he provided the patient sample that had caused discrepant results.Within the shelf life of the supposedly defective lot, our quality control laboratory team tested their retention sample on the ih-1000.The testing was performed with several weak reaction antibodies and controls.All positive and negative reactions were correct.They were also correctly evaluated by the instrument.We did not observe any false negative reaction.At the time we received the patient sample the supposedly defective lot was expired.So our quality control laboratory tested the patient sample, donor samples and weak reacting antibodies (anti-d, anti-k, anti-fy(a) and 2 x jk(a)) with two lots of ih-cell pool on ih-1000.The patient sample showed clearly negative results with both lots.The weak reaction antibodies and the donor samples showed correct results.The evaluation of the instrument was also completely correct.Additionally, the patient sample was tested in further methods.Due to the small amount of patient material the tests were performed with biotestcell 1&2 and biotestcell pool.An auto control could not be performed, because the red blood cells of the patient were not provided, only the plasma.Based on the results in the isotonic saline test in the cold and the enzyme test with bromelin there was a well-founded suspicion for a cold auto or allo antibody.Whether the weak positive reactions in the peg-iat were caused by a specific respectively transfusion-relevant antibodywould only be clarified by further testing.But further tests were not possible, because the patient sample was exhausted.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Trace fileds and data bases of the affected instrument ih-1000 were provided for investigation and analyzes for any issue relevant anomalies.One test reaction looked not clean negative but was near to the "?" interpretation.As the sharpness was too low, this could affect the algorithm image analyses of the wells.A field service engineer adjusted the clearness from 10 to 68 per the job aide.Based on the investigation the complaint was classified as confirmed upp.The negative interpretated result of ih-1000 sn (b)(6) was due to the mixture of low sharpness, limitation of algorithm and suspected cold-reactive antibody.The reaction was not as positive as on the ih-1000 sn (b)(6), but nevertheless it did not clearly look negative, although the instrument called it negative.Based on the outcome of the investigation for the ih-1000 sn (b)(6) we highly recommended correcting the sharpness and checking the camera.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS IH-CELL POOL
• Common Device Name: IH-CELL POOL; 10 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 12810994
• Report Number: 9610824-2021-00076
• Device Sequence Number: 5548150
• Product Code: QHT
• UDI-Device Identifier: 07611969952281
• UDI-Public: (01)07611969952281(17)211025(10)9134011
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 10/25/2021
• Device Catalogue Number: 814060100
• Device Lot Number: 9134011
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 08/23/2022
• 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-1000, SN (B)(6).; IH-1000, SN (B)(6).; IH-1000, SN (B)(6).; IH-1000, SN (B)(6).
• Patient Sex: Unknown