MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SHBG; TESTOSTERONE TEST SYSTEM

Catalog Number 08K26

Device Problem Low Test Results (2458)

Patient Problem Misdiagnosis (2159)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

Correction/removal reporting number: 3002809144-04/18/17-001-c was too long to fit in section.A product correction letter was issued to all customers who received one or more of the architect shbg reagent lots listed below.The customers were instructed to immediately discontinue use of potassium edta specimen tube types with the architect shbg assay.A kit stuffer will be included with all current inventory advising the customer to discontinue the use of potassium edta tube types.The reagent package insert for all future lots of architect shbg has been updated to remove potassium edta tubes as an acceptable tube type for specimen collection.All in-date architect shbg lot numbers are impacted as follows: list number, lot number, manufacture date, expiration date 8k26-20, 01916e000, 13-jun-2016, 25-apr-2017 8k26-20, 00316f000, 04-jul-2016, 27-may-2017 8k26-20, 01816g000, 31-aug-2016, 12-jul-2017 8k26-20, 00916i000, 05-oct-2016, 05-sep-2017 8k26-20, 07316i000, 07-dec-2016, 21-oct-2017 8k26-20, 00916l000, 20-jan-2017, 16-dec-2017 8k26-25, 01816e000, 13-jun-2016, 25-apr-2017 8k26-25, 00216f000, 04-jul-2016, 27-may-2017 8k26-25, 01716g000, 31-aug-2016, 12-jul-2017 8k26-25, 00816i000, 05-oct-2016, 05-sep-2017 8k26-25, 07216i000, 07-dec-2016, 21-oct-2017.

Event Description

Abbott laboratories has identified a potential for falsely decreased architect shbg results to be generated when using the architect shbg assay with the potassium edta specimen tube type.This may also result in an increase in free androgen index / free testosterone index calculations of up to 30% when using potassium edta specimen tubes.No patient injury has been reported due to this issue.

• Brand Name: ARCHITECT SHBG
• Type of Device: TESTOSTERONE TEST SYSTEM
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6552913
• MDR Text Key: 74762206
• Report Number: 3002809144-2017-00034
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08K26
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 3002809144-04/18/17-001-
• Patient Sequence Number: 1
• Treatment: ARCHITECT ISYSTEM ANALYZER