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

Model Number	7K78-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 reported a false positive architect b-hcg result on one patient.The results provided were: sid2336194 - initial = 246.61 miu/ml/ repeat = <1.2 / repeat 2x both were negative.There was no reported impact to patient management.There was no additional patient information provided.
Additional Manufacturer Narrative
The customer observed a false positive result while using the architect total b-hcg reagent lot 73021ui01.The architect i2000sr, serial number (b)(4) instrument logs were reviewed but did not identify conclusive information to indicate an instrument or sample integrity issue occurred.A review of tickets for architect b-hcg, lot 73021ui01, did not identify an increase in complaints related to false positive results and no trends for the reported issue.Historical performance of the architect total b-hcg, lot 73021ui00 was evaluated using world wide data from abbott link.Lot 73021ui00 was reviewed since lot 73021ui01 is a sublot.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 73021ui00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 73021ui00.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of product labeling concluded that the issue was sufficiently addressed.Based on the investigation no product deficiency was identified for the architect total b-hcg, lot 73021ui01.

• 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: 6886877
• Report Number: 3005094123-2017-00060
• Device Sequence Number: 13658029
• Product Code: DHA
• UDI-Device Identifier: 00380740106003
• UDI-Public: (01)00380740106003
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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: 02/13/2018
• Device Model Number: 7K78-35
• Device Catalogue Number: 07K78-35
• Device Lot Number: 73021UI01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR