MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-1000 AUTOMATED ANALYZER SYSTEM; IH-1000 (AUTOMATED ANALYZER SYSTEM)

Catalog Number 001100

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

This is our intial report on this incident.

Event Description

The customer reported question mark respectively 1+ false positive reactions in the forward testing of the ih-card abo/d(dvi-)+rev.A1, b on ih-1000.The customer stated that the affected reactions were visually clearly negative.The customer did not provide a clear date of event but stated that the issue is "ongoing".Because no specific dates were provided, we refrain from submitting several mdrs for this complaint.The customer did neither return the complaint sample ih-card abo/d/dvi-)+rev.A1, b for investigational testing nor the patient samples that had caused question mark respectively 1+ false positive reactions.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot on ih-1000.The testing was performed with different donor samples of different blood groups and rh phenotypes.All positive and negative reactions were correct.We did neither observe any false positive nor equivocal results.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.We are still waiting for the trace files of the affected ih-1000 to be analyzed.

Manufacturer Narrative

This is our final report on this incident.Our initial report was issued for ih-card abo/d(dvi-)+rev a1,b lot: 9125020 but since our investigation showed that not the card but the instrument contributed to the incident, we amended our final report accordingly.

Event Description

The customer reported question mark respectively 1+ false positive reactions in the forward testing of the ih-card abo/d(dvi-)+rev.A1, b on the ih-1000.The customer stated that the affected reactions were visually clearly negative.The customer provided images which showed equivocal result interpretations.The customer did not provide a clear date of event but stated that the issue is "ongoing".Because no specific dates were provided, we refrain from submitting several mdrs for this complaint.The customer did neither return the complaint sample ih-card abo/d/dvi-) +rev.A1, b nor the patient samples that caused question mark respectively 1+ false positive reactions.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot on ih-1000.The testing was performed with different donor samples of different blood groups and rh phenotypes.All positive and negative reactions were correct.We did neither observe any false positive nor equivocal results.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Regarding the affected ih-1000 instrument: the trace files were investigated.We have analyzed the concerned ih card lot by using a different calibration with the following result: the anti a wells is interpreted as negative, the anti b wells is interpreted as negative.We could deduce that the ih-1000's camera needed to be fine-tuned.We also checked the ih card images of the 24th september, we noticed the presence of few dusts on some ih cards.Based on the investigation of the trace files the complaint was classified as confirmed - upp.The result of the investigation was that a fine-tuning of the camera is necessary.This need was already forwarded to the us colleague.It could be shown that equivocal results were correctly negative with a different calibration.As an additional outcome of the investigation (dust in the ih-cards) we highly recommended checking the storage conditions at customer´s site.In this matter we would like to refer to the relevant passage of the ifu (instruction for use): storage requirements store at 18 to 25°c.Do not use beyond expiry on the label, which is expressed as yyyy-mm-dd (year-month-day).Store in an upright position.Do not freeze or expose cards to excessive heat.Do not store near any heat, air conditioning sources or ventilation outlets.

• Brand Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Type of Device: IH-1000 (AUTOMATED ANALYZER SYSTEM)
• 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: 12656587
• MDR Text Key: 277421103
• Report Number: 9610824-2021-00069
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)221022(19)9125020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Catalogue Number: 001100
• Device Lot Number: 9125020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IH-1000, SN: (B)(6).; IH-CARD ABO/D(DVI-)+REV A1,B LOT 9125020.