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

Model Number 7K78-30

Device Problem False Negative Result (1225)

Patient Problems Ectopic Pregnancy (1819); No Code Available (3191)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account stated on (b)(6) 2019 a patient generated a false negative architect total bhcg (<1.2 miu/ml) result but the urine pregnancy test was positive.Additional testing was performed by roche platform with a negative hcg result.The negative architect total bhcg result was reported out of the laboratory.More than 20 days later ((b)(6) 2019), the patient was rushed to the hospital and found that the fallopian tube ruptured and the diagnosis was ectopic pregnancy.One side of the fallopian tube was removed.Additional patient testing was progesterone of 1.7 ng/ml, tsh of 2.09 miu/l and positive urine pregnancy test on (b)(6) 2019.No additional patient information was provided.

Manufacturer Narrative

The ticket searches determined that complaint activity for the issue under review was normal.The complaint trending report review determined that there are no adverse trends for the product for the complaint issue.Labeling was reviewed which adequately addresses the current issue.A review of the product quality history for the lot number using search of the corrective and preventive actions system did not identify issues associated with the customer observation.No customer returns were available for evaluation.A testing protocol was completed using retained samples.All validity and acceptance criteria were met demonstrating that the lot is performing acceptably.No product deficiency was 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: 9321995
• MDR Text Key: 176773350
• Report Number: 3005094123-2019-00319
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2020
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 01177UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR LIST 03M74-02; ARCHITECT I2000SR LIST 03M74-02; SERIAL (B)(6) ; SERIAL (B)(6)
• Patient Outcome(s): Disability
• Patient Age: 22 YR