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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IH-1000 AUTOMATED ANALYZER SYSTEM
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IH-1000 AUTOMATED ANALYZER SYSTEM Back to Search Results
Catalog Number 001100
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2023
Event Type  malfunction  
Event Description
The customer reported false positive reactions of patient samples with the anti-b of ih-card abo/d(dvi-)+rev.A1, b on their ih-1000 instrument.The customer stated that the reactions were rated as 1+ positive but yielded a negative result in manual gel testing with the same card lot number.Visual inspection of the ih-1000 pictures of the abo/d cards had a hazy appearance the anti-b wells.The customer used two different card lots and we filed reports 9610824-2023-00044, 9610824-2023-00045 & 9610824-2023-00046 for the first used lot of ih-cards.The customer did neither provide the complaint sample for investigational testing nor the patient samples that had caused the false positive test results.Therefore our quality control laboratory investigated the retention sample of the supposedly defective lot.First, the retention sample was visually checked for intact sealing, homogeneous gel, correct filling height and absence of splashes in the reaction chamber.All acceptance criteria were met.Then our quality control laboratory tested their retention sample with different donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any false positive or hazy reaction.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.A field service engineer was sent to the customer's site to investigate the affected instrument and to collect trace files.Evaluation of these data is still ongoing.-.
 
Manufacturer Narrative
This is our initial report on this incident.
 
Manufacturer Narrative
This is our final report on this incident.
 
Event Description
The customer reported false positive reactions of patient samples with the anti-b of ih-card abo/d(dvi-)+rev.A1, b on their ih-1000 instrument.The customer stated that the reactions were rated as 1+ positive but yielded a negative result in manual gel testing with the same card lot number.Visual inspection of the ih-1000 pictures of the abo/d cards had a hazy appearance the anti-b wells.The customer used two different card lots and we filed reports 9610824-2023-00044, 9610824-2023-00045 & 9610824-2023-00046 for the first used lot of ih-cards.The customer did neither provide the complaint sample for investigational testing nor the patient samples that had caused the false positive test results.Therefore our quality control laboratory investigated the retention sample of the supposedly defective lot.First, the retention sample was visually checked for intact sealing, homogeneous gel, correct filling height and absence of splashes in the reaction chamber.All acceptance criteria were met.Then our quality control laboratory tested their retention sample with different donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any false positive or hazy reaction.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.A field service engineer was sent to the customer's site to investigate the affected instrument and to collect trace files.The investigation of the instrument data confirmed the customer's complaint.The received databases and files were analyzed for any issue relevant anomalies.The images were processed by r&d and the 1+ reaction with the anti-b were graded negatively for all the cards analyzed.The 1+ reaction observed by the end-user could be explained by a contrast that is too high.A field service engineer was dispatched to perform the calibration of the camera and check the card barcode sharpness.We submitted our initial reports for this incident for the ih-cards used by the customer.Since our investigation showed that the incident was caused by the instrument, we changed the changed the suspected medical device from the affected ih-card to the affected instrument ih-1000.
 
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Brand Name
IH-1000 AUTOMATED ANALYZER SYSTEM
Type of Device
IH-1000 AUTOMATED ANALYZER SYSTEM
Manufacturer Contact
martina benkert
industriestrasse 1
dreieich, 63303
GM   63303
MDR Report Key17601358
MDR Text Key321722555
Report Number9610824-2023-00049
Device Sequence Number1
Product Code KSZ
UDI-Device Identifier07611969205493
UDI-Public(01)07611969205493
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK170019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date03/28/2024
Device Catalogue Number001100
Device Lot Number9248010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2023
Was Device Evaluated by Manufacturer? Yes
Patient Sequence Number1
Treatment
IH-1000, SN (B)(6); IH-CARD ABO/D(DVI-)+REV A1,B LOT 9243010; IH-CARD ABO/D(DVI-)+REV A1,B, LOT 9248010
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