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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 REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

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A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN Back to Search Results
Catalog Number 07K78-77
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/03/2021
Event Type  malfunction  
Manufacturer Narrative
This issue was previously reported under mdr number 3016438761-2021-00266 under a different suspect medical device.The suspect medical device was changed on (b)(6) 2021 upon further investigation of the customer issue.Historical quality metrics review determined normal complaint activity for the lot.Complaint trending report review determined that there is no related non-statistical or adverse trend for the product.Labelling review concluded that the issue is adequately addressed.Historical performance in the field of the reagent lot using worldwide data through abbottlink was evaluated.The median population result for the lot is within established baselines and comparable with all other lots in the field and confirms no systemic issue for this lot.A malfunction was not identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.The test results generated were caused by incorrect formulation of the wash buffer.
 
Event Description
The customer reported false negative architect b-hcg results on one patient.The results provided were: initial = 3.8miu/ml (<5.00miu/ml = negative); about 3 pm on a different module the result = 387miu/ml(>/=25.00miu/ml = positive).The controls were within range in the morning and the negative result was generated at noon.There was no reported impact to patient management.
 
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Brand Name
ARCHITECT TOTAL B-HCG REAGENT KIT
Type of Device
SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
Manufacturer (Section D)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford N39E9 32
EI  N39E932
Manufacturer (Section G)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford N39E9 32
EI   N39E932
Manufacturer Contact
christian lee
100 abbott park road
dept. 09b9, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key12555757
MDR Text Key274079787
Report Number3005094123-2021-00187
Device Sequence Number1
Product Code DHA
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 09/30/2021
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 Date08/06/2021
Device Catalogue Number07K78-77
Device Lot Number19561UI01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/17/2021
Initial Date FDA Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
ARC I2000SR INST, 03M74-02, ISR55825
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