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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TOTAL B HCG; HUMAN CHORIONIC GONADOTROPIN

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A.I.D.D LONGFORD ALINITY I TOTAL B HCG; HUMAN CHORIONIC GONADOTROPIN Back to Search Results
Catalog Number 07P51-20
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2019
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 false negative alinity i total b-hcg result for 1 sample that was auto diluted on the alinity.The following data was provided (units of measure iu/l): sid (b)(6) initial result (undiluted) = 431.49, repeats (undiluted) = 445.45, 401.99, 424.30.Auto diluted (1:15) result = <2 iu/l (not reported out of the laboratory).No impact to patient management was reported.
 
Manufacturer Narrative
There was a typographical error identified on (b)(6) 2019.The incorrect g4 date was submitted in follow-up 02 as 09/16/2018.The correct date is 09/16/2019.
 
Manufacturer Narrative
The following statement was inadvertently not included in the initial mdr: this report is being filed on an international product, list number 7p51-20 that has a similar product distributed in the us, list number 7p51-21 and 7p51-31.
 
Manufacturer Narrative
A review of tickets was performed for reagent lot number 93113ui00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did identify trends for the product, however the trends are not related to lot 93113ui00.Return testing was not completed as returns were not available.A testing protocol was executed using retained product samples, all validity and acceptance criteria were met.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.The customer reported that results of 431.39, 445.45, 401.99 and 424.30iu/l were reported for the sample, upon dilution a result of <2iu/l was reported.Per package insert the result should be > 467.00 miu/ml (> 467.00 iu/l) before the dilution factor is applied.If the operator does not enter the dilution factor, the result must be manually multiplied by the appropriate dilution factor before reporting the result.If a diluted sample result is < 467.00 miu/ml (< 467.00 iu/l), do not report the result.Rerun using an appropriate dilution.Note: a printed or displayed result of < 7000.00 miu/ml (1:15 automated dilution protocol) indicates the need to retest the sample at a lower dilution or undiluted.The result and interpretation should not be reported.Based on the investigation no systemic issue or deficiency of the alinity i b-hcg assay for lot 93113ui00 was identified.
 
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Brand Name
ALINITY I TOTAL B HCG
Type of Device
HUMAN CHORIONIC GONADOTROPIN
Manufacturer (Section D)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford NA
EI  NA
MDR Report Key8748324
MDR Text Key149690452
Report Number3005094123-2019-00184
Device Sequence Number1
Product Code DHA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/07/2019
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 Date10/12/2019
Device Catalogue Number07P51-20
Device Lot Number93113UI00
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/01/2019
Initial Date FDA Received07/01/2019
Supplement Dates Manufacturer Received07/01/2019
09/16/2018
10/04/2019
Supplement Dates FDA Received07/01/2019
09/18/2019
10/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALINITY I ANALYZER, SERIAL (B)(6); ALINITY I ANALYZER, SERIAL (B)(6); ALINITY I ANALYZER, SERIAL (B)(6); ALINITY I ANALYZER, SERIAL (B)(6); LIST 3R65-01; LIST 3R65-01; LIST 3R65-01; LIST 3R65-01; ALINITY I ANALYZER, SERIAL (B)(4); LIST 3R65-01
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