MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Catalog Number 08D06-77

Device Problem Low Test Results (2458)

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

Event Date 02/02/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided by the customer.This report is being filed on an international product, list number 8d06-77 that has a similar product distributed in the us, list number 8d06-41.

Event Description

The customer reported (b)(6) architect syphilis results on one known (b)(6) patient.The results provide were: (b)(6) 2020 initial = (b)(6) / retest = (b)(6) / tppa = (b)(6) / wantai (elisa) method = (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

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

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 07415be01 and no trends were identified for the complaint issue.Returns are available, however, due to coronavirus outbreaks in china ,and to reduce risk of spreading the virus, ehs (environment, health and safety) of shanghai lab does not permit to receive samples from hospital as specimen could potentially be infected.Sensitivity testing was performed with a retained kit of 07415be00 (lot number 07415be01 contains the same bulk material) and results of this setup did not implicate that the performance of the used lots is negatively impacted.No false non-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 07415be01.

• 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: 9759181
• MDR Text Key: 194115882
• Report Number: 3002809144-2020-00139
• 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: 07/08/2020
• Device Catalogue Number: 08D06-77
• Device Lot Number: 07415BE01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/09/2020; 06/15/2020
• Supplement Dates FDA Received: 03/11/2020; 06/16/2020
• 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,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4); SERIAL #(B)(4)
• Patient Age: 55 YR