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

Model Number	7K78-35
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
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 imprecise architect total b-hcg results were generated.Patient 2: 29 miu/ml (b)(6) and less than 5 miu/ml (b)(6) twice.The result of 29 miu/ml is suspected to be falsely (b)(6).No adverse impact to patient management was reported.
Additional Manufacturer Narrative
The suspect medical device in the initial mdr was incorrect.Mdr number 1628664-2018-00001 has been submitted with the correct suspect medical device and all further information will be documented under that mdr number.

• 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: 7157031
• Report Number: 3005094123-2018-00001
• Device Sequence Number: 11007990
• Product Code: DHA
• UDI-Device Identifier: 00380740106003
• UDI-Public: (01)00380740106003(17)180630(10)78132UI00
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2018

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 Model Number: 7K78-35
• Device Catalogue Number: 07K78-35
• Device Lot Number: 78132UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1