MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT BNP CONTROLS

Catalog Number 08K28-12

Device Problem High Test Results (2457)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

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 biorad controls shift high on the architect bnp assay.The customer indicated the assay was calibrated with control lot 44k82018.There was no report of incorrect patient results or impact to patient management.

Manufacturer Narrative

After further evaluation, the suspect medical device architect bnp controls, list 08k28-12, lot 44k82818, manufacturing site (b)(4) is no longer considered a likely cause.Therefore, this medical device report is not related to remedial action 3002809144-06/4/19-006-r and is unassigned from the field action.Refer to mdr 3002809144-2019-00382 which was submitted for the customer's issue on an alternate suspect medical device.

• Brand Name: ARCHITECT BNP CONTROLS
• Type of Device: BNP CONTROLS
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8743585
• MDR Text Key: 149705255
• Report Number: 3002809144-2019-00383
• Device Sequence Number: 1
• Product Code: JJX
• UDI-Device Identifier: 00380740145262
• UDI-Public: 00380740145262
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

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: 11/15/2019
• Device Catalogue Number: 08K28-12
• Device Lot Number: 44K82818
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3002809144-06/4/19-006R
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER, LN 01L86-40; ARCHITECT I1000SR ANALYZER, LN 01L86-40; SN (B)(4); SN (B)(4)