MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Catalog Number 08D06-32

Device Problem False Negative Result (1225)

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

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.This report is being filed on an international product, list number 8d06-32 that has a similar product distributed in the us, list number 8d06-31.

Event Description

The customer reported a false nonreactive architect (b)(6) result on a patient with syphilis symptoms.The results provided were: on (b)(6) 2020 (b)(6) architect= 0.07s/co (<1.00s/co =nonreactive); vdrl=positive; tpha =negative; elisa = negative; fta-abs igg=positive, igm =negative.There was no reported impact to patient management.

Manufacturer Narrative

Correction to section d.Suspect medical device, 2.Product code: from incorrect mtn to correct lip.The complaint investigation for a false nonreactive result for one sample tested with the architect syphilis tp assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and inhouse testing of retained kits.Trending review determined no trends for the issue for the product.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 07414be00 and no false nonreactive results were obtained, indicating that the sensitivity performance of the lot is not negatively impacted.Device history record review of the lot did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation no systemic issue or deficiency was identified for the architect syphilis tp reagent, lot 07414be00.

• Brand Name: ARCHITECT SYPHILIS TP
• Type of Device: SYPHILIS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10123276
• MDR Text Key: 228395703
• Report Number: 3002809144-2020-00446
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2020
• Device Catalogue Number: 08D06-32
• Device Lot Number: 07414BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-02,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(6); SERIAL # (B)(6)