MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-500

Catalog Number 001510

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

Patient Problem Test Result (2695)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported abo blood group discrepancies of three samples when tested using ih-card abo/d(dvi-)+rev.A1, b on ih-500: issue 1- the customer ran an abo/d determination along with the abo blood group confirmation of a control reagent.The blood group was a negative but the abo blood group confirmation was typed as an blood group ab.The customer reran the abo blood group confirmation and it was typed as an a negative.Issue 2- the customer ran 3 patients samples.The customer confirmed there were two patient samples with blood group a rh(d) positive that were performed before the third patient.The third patient had a history of typing as an blood group o rh(d) positive.The sample was forward typed as an blood group a rh(d) positive and reverse typed as a blood group o.The customer performed a manual tube test and the sample resulted as blood group o rh(d) positive.Issue 3- the customer ran another patient on the ih-500 that was forward typed as a blood group b rh(d) positive but reversed typed as a blood group o.The customer performed a manual tube test and the sample resulted as blood group b rh(d) positive.The customer did neither return the supposedly defective product ih-card abo/d(dvi-)+rev.A1, b for investigational testing nor the patient samples that had caused false positive test results.Therefore our quality control laboratory tested their retention sample of ih-card abo/d(dvi-)+rev.A1, b on ih-500.The testing is still ongoing.Furthermore we are still waiting for the requested files of ih-500 in order to investigate them.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 abo blood group discrepancies of three samples when tested using ih-card abo/d(dvi-)+rev.A1, b on ih-500: issue 1- the customer ran an abo/d determination along with the abo blood group confirmation of a control reagent.The blood group was a negative but the abo blood group confirmation was typed as an blood group ab.The customer reran the abo blood group confirmation and it was typed as an a negative.Issue 2- the customer ran 3 patients samples.The customer confirmed there were two patient samples with blood group a rh(d) positive that were performed before the third patient.The third patient had a history of typing as an blood group o rh(d) positive.The sample was forward typed as an blood group a rh(d) positive and reverse typed as a blood group o.The customer performed a manual tube test and the sample resulted as blood group o rh(d) positive.Issue 3- the customer ran another patient on the ih-500 that was forward typed as a blood group b rh(d) positive but reversed typed as a blood group o.The customer performed a manual tube test and the sample resulted as blood group b rh(d) positive.The customer did neither return the supposedly defective product ih-card abo/d(dvi-)+rev.A1, b for investigational testing nor the patient samples that had caused false positive test results.Therefore our quality control laboratory tested their retention sample of ih-card abo/d(dvi-)+rev.A1, b on the ih-500: seven donor samples (2 x a1, 1 x o, 3 x b and 1 x a1, b) were tested.All positive and negative reactions were correct.Additionally the retention sample was visually checked for visible supernatant, intact sealing and homogeneous gel.All acceptance criteria were met.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected ih-500 was inspected by our field service engineers.The issue was found to be related with a hardware issue.It was detected that there was an issue regarding the connection to the sodium hydroxide was not connected correctly and the instrument was not drawing the sodium hydroxide properly.After the intervention of the field service engineer the problem was resolved and we have obtained the confirmation that issues were resolved.Our initial report was issued for ih-card abo/d(dvi-)+rev.A1, b.Since it turned out that the problem was related to the customer's ih-500, our final report is issued for the ih-500.

Manufacturer Narrative

This is our final report on this incident.

• Brand Name: IH-500
• Type of Device: IH-500
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 9726463
• MDR Text Key: 204775927
• Report Number: 9610824-2020-00005
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)201220(10)8934020
• Combination Product (y/n): N
• PMA/PMN Number: BK180274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2020
• Device Catalogue Number: 001510
• Device Lot Number: 8934020
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IH 1000, # 5100018; IH 1000, # 5100018; IH CARD AHG ANTI-IGG, LOT 8933060; IH CARD AHG ANTI-IGG, LOT 8933060; IH-CARD ABO/D(DVI-)+REV A1,B, LOT 8934020; IH-CELL A1&B, LOT 8950011; IH-CELL A1&B, LOT 8950011; IH-CELL I-II-III, LOT 8950011; IH-CELL I-II-III, LOT 8950011