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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HE4 REAGENT KIT; TEST, EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4)
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ABBOTT GMBH ALINITY I HE4 REAGENT KIT; TEST, EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4) Back to Search Results
Catalog Number 08P50-22
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
Event Description
The customer observed falsely decreased alinity i he4 results which does not meet with previous results on one patient.The results provided were: (b)(6) 2022 sid (b)(6)10=60.3 pmol/l /repeated on (b)(6) 2022=149.6 pmol/l the precision data provided for troubleshooting purpose.There was no reported impact to patient management.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and in-house testing of alinity i he4 reagent kit, lot 36593fp00.The ticket search determined that there is normal complaint activity for the likely cause lot.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.A specificity testing was performed on internal alinity i he4 panel with a retained kit of lot 36593fp00.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing as expected.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i he4 reagent kit, lot 36593fp00.
 
Event Description
The customer observed falsely decreased alinity i he4 results which does not meet with previous results on one patient.The results provided were: (b)(6) 2022 sid (b)(6) =60.3 pmol/l /repeated on (b)(6) 2022=149.6 pmol/l the precision data provided for troubleshooting purpose.There was no reported impact to patient management.
 
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Brand Name
ALINITY I HE4 REAGENT KIT
Type of Device
TEST, EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4)
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM   65205
Manufacturer Contact
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key14887979
MDR Text Key303318820
Report Number3002809144-2022-00227
Device Sequence Number1
Product Code OIU
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K093957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Expiration Date11/10/2022
Device Catalogue Number08P50-22
Device Lot Number36593FP00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/14/2022
Initial Date FDA Received07/01/2022
Supplement Dates Manufacturer Received08/23/2022
Supplement Dates FDA Received08/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
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