MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG

Catalog Number	7K78-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).
Event or Problem Description
The customer observed false negative architect b-hcg results.The customer provided data for one pregnant patient, as follows (miu/ml): (b)(6).There was no adverse impact to patient management reported.
Additional Manufacturer Narrative
Susepct device lot number was added.An evaluation is in-process.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, in-house testing, field data review, design history record review, a search for similar complaints, and a review of labeling.Return material was not available from the customer.An accuracy testing protocol was performed using an in-house retain kit and all specifications were met indicating the lot is preforming acceptably.An analysis utilizing field data was completed to determine if the median patient values have shifted over time.The analysis concluded that the medians of patient results are within the established limits for lot 82186ui00.The design history record review did not identify any non-conformances, deviations or potential nonconformances of the lot in question.Tracking and trending did not identify an adverse trend for the lot in question.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect total b-hcg reagent, list 07k78, lot 82186ui00, was identified.

• Brand Name: ARCHITECT TOTAL B-HCG
• Common Device Name: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 7875699
• Report Number: 3005094123-2018-00047
• Device Sequence Number: 16190997
• Product Code: DHA
• UDI-Device Identifier: 00380740014933
• UDI-Public: 00380740014933
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2018
• Device Catalogue Number: 7K78-30
• Device Lot Number: 82186UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2018
• Supplement Date Received by Manufacturer: 09/16/2018; 11/14/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/04/2018; 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02, SN (B)(4); LN 03M74-02, SN (B)(4); LN 03M74-02, SN (B)(4)