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 Patient Involvement (2645)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer obtained falsely elevated and failing (b)(6) survey results while using the architect bnp calibrator lot 44k82018.Sample (b)(6) generated a result of 1319.6 with an expected range of 789 to 1239.6 and sample (b)(6) generated a result of >5000 with an expected range of 3579.0 to 4928.7.There was no report of incorrect patient results or impact to patient management.

• 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: 8860955
• Report Number: 3002809144-2019-00483
• Device Sequence Number: 525463
• Product Code: JIT
• UDI-Device Identifier: 00380740145255
• UDI-Public: 00380740145255
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: 10/09/2019
• Device Catalogue Number: 08K28-03
• Device Lot Number: 44K82018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/05/2019
• 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