MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT BNP CALIBRATORS

Catalog Number	08K28-03
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BNP CALIBRATORS
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8797646
• Report Number: 3002809144-2019-00438
• Device Sequence Number: 3205845
• Product Code: JIT
• UDI-Device Identifier: 00380740145255
• UDI-Public: 00380740145255
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2019
• Device Catalogue Number: 08K28-03
• Device Lot Number: 44K79418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002809144-06/4/19-006R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR, LIST 03M74-97; SERIAL (B)(4)