MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TOTAL B-HCG REAGENT KIT

Catalog Number	07P51-31
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
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.
Event or Problem Description
The customer stated that false positive alinity i total b-hcg results of 228 iu/l and 221 iu/l were generated for two different patient samples (sids (b)(6)) that retested negative at <2.0 iu/l.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
After further review, the suspect medical device changed from the alinity i total b-hcg reagent (manufacturing site aidd longford, ireland) to the alinity i processing module (manufacturing site wiesbaden, germany) on october 16, 2019.New mdr number 3002809144-2019-00861 has been submited and all further information will be documented under that mdr number.

• Brand Name: ALINITY I TOTAL B-HCG REAGENT KIT
• Common Device Name: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8841733
• Report Number: 3005094123-2019-00216
• Device Sequence Number: 311669
• Product Code: DHA
• UDI-Device Identifier: 00380740160623
• UDI-Public: 00380740160623
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 11/12/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07P51-31
• Device Lot Number: 01178UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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: ALINITY I PROCESSING MODULE; ALINITY I PROCESSING MODULE; LIST 03R65-01, SERIAL (B)(4); LIST 03R65-01, SERIAL (B)(4)