MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1; IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS

Catalog Number 813112100

Device Problems False Positive Result (1227); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported rh d discrepant results of one female patient with ih-card abo/d(dvi-) +rev.A1, b on ih-1000.This patient was typed as blood group ab rhd negative at an outside laboratory on april 1st 2019.On (b)(6) 2019 a new sample of the patient was drawn and tested with ih-card abo/d(dvi-) +rev.A1,b lot # 8845100, b on ih-1000 (serial number # (b)(4)).The customer stated that the female patient was typed as blood group ab rhd positive.The customer did not return the supposedly defective product for investigational testing but the patient sample that had caused discrepant results.Testing in our quality control laboratory and an external laboratory 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.

Manufacturer Narrative

This is our final report on this incident.It could clearly be demonstrated that the patient sample was a d type that had to react positively with the anti-d of the ih-card abo/d (dvi-)+rev.A1, b.

Event Description

The customer reported rh d discrepant results of one female patient.The female patient was first typed at an outside lab as blood group ab rhd negative.On (b)(6) 2019 a new sample of the patient was drawn and tested with ih-card abo/d (dvi-) +rev.A1, b on ih-1000.The female patient was typed as blood group ab rhd positive.The customer did return the patient sample that had caused the discrepant result for investigational testing but not the supposedly defective product.Therefore our quality control laboratory tested the patient sample with their retention sample of the supposedly defective lot.Due to the small amount of the patient sample the testing was done manually.The patient sample yielded a 3+ positive result with the anti-d.Furthermore the patient sample was sent to an external laboratory for molecular typing of the rhd.Based on the internal evaluation of the external raw data, it could clearly be demonstrated that the patient sample was a d type that had to react positively with the anti-d of the ih-card abo/d(dvi-) +rev.A1, b.Testing by our quality control laboratory confirmed the correct function of the allegedly defective lot of ih-card abo/d (dvi-)+rev.A1, b.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

Event Description

The customer reported rh d discrepant results of one female patient with ih-card abo/d(dvi-) +rev.A1, b on ih-1000.This female patient was first typed as blood group ab rhd negative at an outside laboratory on april 1st 2019.On may 29, 2019 a new sample of the patient was drawn and tested with ih-card abo/d(dvi-) +rev.A1,b lot # 8845100, b on ih-1000.The customer stated that the female patient was typed as blood group ab rhd positive.The customer did not return the supposedly defective product for investigational testing but the patient sample that had caused the discrepant test result.Therefore our quality control laboratory tested the patient sample with their retention sample of the supposedly defective lot.Due to the small amount of the patient sample the testing was done manually.The patient sample yielded a 3+ positive result with the anti-d.The patient sample was also sent to an external laboratory for molecular typing of the rhd.The outcome of the external testing is: rhd * dvi.1 (a273a).It confirms the existence of a d variant.Nevertheless the patient sample yielded a correctly positive result with the anti-d of the ih-card.Testing by our quality control laboratory confirmed the correct function of the allegedly defective lot of ih-card abo/d(dvi-)+rev.A1, b.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

Manufacturer Narrative

This is our final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1
• Type of Device: IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 8762148
• MDR Text Key: 151032140
• Report Number: 9610824-2019-00029
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)200308(10)8845100
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2020
• Device Catalogue Number: 813112100
• Device Lot Number: 8845100
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/17/2019
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IH-1000, # 5100078; IH-1000, # 5100078; IH-1000, # 5100078