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

Catalog Number 07K78-35

Device Problem High Readings (2459)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = sid (b)(6) / new draw same patient, sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no further patient information provided by the customer.

Event Description

The customer reported falsely elevated architect b-hcg results on one patient.The results provided were: sid (b)(6) initial = 9695.32miu/ml (>/=25.0miu/ml = positive) / new draw same patient, sid (b)(6) retest = <1.5miu/ml (

Manufacturer Narrative

A review of the complaint trending report determined that there are no adverse trends for the product, however a non-statistical trend was identified related to the issue under review.Return testing was not completed as returns were not available.Historical performance in the field of reagent lots using world wide data through abbottlink was evaluated.The patient median result for lot 85141ui00 is comparable with all other lots in the field within established baselines, confirming no systemic issue for the lot.Accuracy testing was performed using a retained kit of lot 85141ui00 and all specifications were met indicating the lot is preforming acceptably.A review of the instrument log file confirmed the customer's observation, however, no instrument issues were identified.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is adequately addressed.Based on the investigation no product deficiency was identified for the architect total b-hcg, lot 85141ui00.

• Brand Name: ARCHITECT TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8101444
• MDR Text Key: 129318233
• Report Number: 3005094123-2018-00178
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• PMA/PMN Number: K983424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Catalogue Number: 07K78-35
• Device Lot Number: 85141UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4). ; SERIAL # (B)(4).