MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT

Catalog Number 07P60-32

Device Problems False Negative Result (1225); Low Test Results (2458)

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

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

There is no further patient information provided due to privacy issues.Complete information for section a patient information, 1.Patient identifier = (b)(6).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 7p60-32 that has a similar product distributed in the us, list number 7p60-31.

Event Description

The customer reported (b)(6) alinity i syphilis results on one patient.The results provided were: on (b)(6) 2020 (b)(6)= 0.08s/co (<1.00s/co = (b)(6) / tpha = >1:80 (cutoff <1:80) (b)(6) / immunoblot igg fta if m quant 1:320 (b)(6) (cutoff <1:10) / retest of sample on a different alinity i analyzer with a different lot = 0.09s/co.There was no reported impact to patient management.

Manufacturer Narrative

Suspect medical device, 2.Common device name from alinity i syphilis tp to syphilis.Device manufacturers only, 6.Event problem and evaluation codes: device code from (b)(4).A review of tickets determined normal complaint activity for lot 11057be00, and no trends were identified for the complaint issue.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 11057be00 and five replicates of positive control.The positive control values met specifications and the results were in the typical range and no false non-reactive results were obtained.Therefore, no unusual reagent lot performance was identified.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 alinity i syphilis tp reagent, lot 11057be00.

Manufacturer Narrative

Corrected information for section d2 product code from incorrect mtn to correct lip.

• Brand Name: ALINITY I SYPHILIS TP REAGENT KIT
• Type of Device: SYPHILIS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9705730
• MDR Text Key: 188029680
• Report Number: 3002809144-2020-00110
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Catalogue Number: 07P60-32
• Device Lot Number: 11057BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 04/13/2020; 06/15/2020
• Supplement Dates FDA Received: 04/15/2020; 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE, LN 03R65-01,; ALINITY I PROCESSING MODULE, LN 03R65-01,; ALINITY I PROCESSING MODULE, LN 03R65-01,; SERIAL # (B)(6); SERIAL # (B)(6); SERIAL # (B)(6)