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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG
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A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG Back to Search Results
Model Number 7K78-25
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed a falsely depressed architect total b-hcg result for a patient with an anembryonic pregnancy.The initial and repeat results were <1.20 miu/ml (negative).The sample was repeated on another architect at a different laboratory and generated the same results.The sample was positive with abon and dialab rapid test kits.
 
Manufacturer Narrative
Additional information was provided by the customer which makes this previously reported issue non-reportable.Clarification was provided that lot number 04522ui00 on mdr number 3005094123-2020-00190 was expired when the discrepant results were generated.The date of event was (b)(6) 2020 and the lot expired on24may2020.No impact to patient management was reported.Based upon this new information, this complaint is no longer a reportable event and no further follow-up will be provided.H3 other text : based upon new information this complaint is no longer a reportable event and no further follow-up will be provided.
 
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Brand Name
ARCHITECT TOTAL B-HCG
Type of Device
B-HCG
Manufacturer (Section D)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford N39E9 32
EI  N39E932
MDR Report Key10466473
MDR Text Key204744055
Report Number3005094123-2020-00190
Device Sequence Number1
Product Code DHA
UDI-Device Identifier00380740014964
UDI-Public00380740014964
Combination Product (y/n)N
PMA/PMN Number
K983424
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7K78-25
Device Catalogue Number07K78-25
Device Lot Number04522UI00
Was Device Available for Evaluation? No
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC BHCG RGT (100T), 07K78-25, 08042UI00; ARC I1000SR INTGR, 01L86-40, I1SR56790; ARC I2K PROC MOD, 03M74-01, ISR08468; ARC I2K PROC MOD, 03M74-01, ISR08468; LIST 07K78-25, LOT 08042UI00; ARCHITECT I1000SR, LIST 01L86-40; LIST 07K78-25, LOT 08042UI00; SERIAL (B)(4), ARCHITECT B-HCG
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