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

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.

• 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 Key: 8748324
• MDR Text Key: 149690452
• Report Number: 3005094123-2019-00184
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Date: 10/12/2019
• Device Catalogue Number: 07P51-20
• Device Lot Number: 93113UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 07/01/2019; 09/16/2018; 10/04/2019
• Supplement Dates FDA Received: 07/01/2019; 09/18/2019; 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• 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