MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT BNP CALIBRATORS

Catalog Number 08K28-03

Device Problem High Test Results (2457)

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

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: multiple = (b)(6).Patient information: no further information was provided.Correction/removal number: 3002809144-06/4/19-006-r.A product recall letter was issued to all architect bnp customers who have received calibrator or control lots still within dating.The letter informs the customer of the issue regarding a time dependent stability issue of the architect bnp calibrators and controls that may lead to controls out of range and shift in control and patient results.The letter informs the customer all architect bnp calibrators and controls will have shortened expiration dates of 165 days from the date of manufacture.The letter instructs the customer to discontinue use of the lots which are beyond the 165 day expiration and destroy any remaining inventory.The cause of the shift is instability of the architect bnp calibrators and controls.

Event Description

The customer observed falsely elevated architect bnp results while using architect bnp calibrator lot 44k79418.The customer provided the following comparison results: sample id (b)(6): 299 ng/l on the complaint lots and 209 ng/l on a new lot; sample id (b)(6): 4917 ng/l on the complaint lots and 4066 ng/l on a new lot; sample id (b)(6): 3420 ng/l on the complaint lots and 2681 ng/l on a new lot; sample id (b)(6): 1992 ng/l on the complaint lots and 1351 ng/l on a new lot; sample id (b)(6): 1105 ng/l on the complaint lots and 850 ng/l on a new lot; sample id (b)(6): 62 ng/l on the complaint lots and 47 ng/l on a new lot.No impact to patient management was reported.

• Brand Name: ARCHITECT BNP CALIBRATORS
• Type of Device: BNP CALIBRATORS
• 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: 8797646
• MDR Text Key: 151345644
• Report Number: 3002809144-2019-00438
• Device Sequence Number: 1
• Product Code: JIT
• UDI-Device Identifier: 00380740145255
• UDI-Public: 00380740145255
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2019
• Device Catalogue Number: 08K28-03
• Device Lot Number: 44K79418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 3002809144-06/4/19-006R
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-97; SERIAL (B)(4)