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

Catalog Number 07K78-30

Device Problem False Negative Result (1225)

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

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer reported a (b)(6) b-hcg result when processing on the architect i2000sr.Retest using the gold standard method was reported to be positive.The patient was a (b)(6) female with the following results generated: (b)(6) 2019- serum b-hcg test result of <1.200 miu/ml on the i2000 analyzer (reference range: non-gravid female <5 miu/ml); colloidal gold serum result was (b)(6) but colloidal gold urine test was a (b)(6).(b)(6) 2019- retest of retained urine and serum specimens, with a serum result of <1.200 miu/ml on the i2000 analyzer, urine test was still strong positive, serum colloidal gold result was (b)(6), luminescence was 441.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, a review of the historical performance, a review of the product quality history, and a review of product labeling.Ticket searches determined normal complaint activity for the lot.The complaint trending report review did not identify any trends.Worldwide field data was used to evaluate the historical performance of the reagent lots and this review determined the lot is comparable with all other lots in the field.A review of the product quality history did not identify any issues.No systemic issues were identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• 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: 9071600
• MDR Text Key: 158773853
• Report Number: 3005094123-2019-00254
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• 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: 12/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2019
• Device Catalogue Number: 07K78-30
• Device Lot Number: 92575UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 11/28/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-02; SN (B)(6)
• Patient Age: 15 YR