MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Catalog Number 08D06-32

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.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.All patient information provided has been included in this report.

Event Description

The customer observed a false (b)(6) architect (b)(6) tp result when processing on the architect i1000sr.The following data was provided for the (b)(6) year old female patient: (b)(6).Generated initial result of (b)(6) on (b)(6) 2020; (b)(6).Due to the false (b)(6) results and for neurological reasons a cerebrospinal sample (csf) was taken and sent to a reference lab.The csf and the serum tested (b)(6) with vitros rpr, tppa, and tpa chemiluminesence ocd.The customer then retested the original sample ((b)(6) on (b)(6) 2020) on architect = (b)(6).This sample was sent to the reference lab where it tested (b)(6).Patient was evaluated at a day clinic for cognitive deficit.Tests included imaging and blood.Imaging report indicated moderately to severely decreased perfusion parietotemporal (re> li) and more limited hippocampal (re> li).Mesial temporal atrophy (mta) grade 2.Also determination of biological markers on lumbar fluid for the diagnosis of alzheimer's.The results of this are indicative of underlying amyloid pathology.

Manufacturer Narrative

A review of tickets determined normal complaint activity for lot 11036be00 and no trends were identified for the product for the issue.Return testing was not completed as returns were not available.Specificity testing was performed with a retained kit of lot 11036be00 and a specificity panel.Results of this setup did not implicate that the performance regarding specificity of the lot is negatively impacted.No false reactive results were obtained.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect syphilis tp reagent, lot 11036be00.

Manufacturer Narrative

Corrected information for product code from incorrect mtn to correct lip.

• 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: 9911522
• MDR Text Key: 187551388
• Report Number: 3002809144-2020-00279
• 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,Followup
• Report Date: 06/16/2020

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: 11/13/2020
• Device Catalogue Number: 08D06-32
• Device Lot Number: 11036BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 04/07/2020; 06/15/2020
• Supplement Dates FDA Received: 04/13/2020; 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR, LN 01L86-01,; ARCHITECT I1000SR, LN 01L86-01,; ARCHITECT I1000SR, LN 01L86-01,; LN 08D06-32, LOT # 10028BE00; SERIAL # (B)(6); SN (B)(6); SN (B)(6) ARCHITECT SYPHILIS TP,
• Patient Outcome(s): Other
• Patient Age: 84 YR