MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT IGENTAMICIN

Model Number	1P31-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot 08510be00, exp 08aug2020; lot 11221be00, exp 18nov2020.Concomitant medical products = architect stat high sensitive troponin-i , list 3p25; architect stat high sensitivity troponin-i assays, list 2r98.Device manufacture date = lot 08510be00- dom 30aug2019; lot 11221be00- dom 05dec2019.Correction/removal report number = 3002809144-04/29/20-003-c.All previous lots are impacted by this issue.The lots listed in this mdr are the only in-date lots.Preliminary results from abbott internal analysis of field data from these two assays show a potential to generate falsely elevated of patient results.The investigation into this issue is in process.A follow-up mdr will be submitted when the root cause has been identified and further, corrective actions may be implemented and communicated upon completion of the investigation.A product correction letter has been issued to all customers who have received the architect igentamicin reagent kit.The product correction letter informs the customer of the issue with the architect igentamicin reagent and provides the customer with the necessary actions to take to mitigate the issue.An evaluation is in process.
Event or Problem Description
Abbott identified that samples tested for architect stat high sensitive troponin-i and stat high sensitivity troponin-i assays (ln 3p25 and ln 2r98) may show interaction when processed directly after the architect igentamicin (ln 1p31-25) assay and patient results might be impacted.There has been no reported harm or impact to patient management as a result of this issue.
Additional Manufacturer Narrative
Continued information for section d4 lot #, expiration date= lot 08510be00, exp 08aug2020; lot 11221be00, exp 18nov2020.Continued information for section d11 concomitant medical products= architect stat high sensitive troponin-i , list 3p25; architect stat high sensitivity troponin-i assays, list 2r98.Complete information for section h9: correction/removal report number = 3002809144-04/29/20-003-c all previous lots are impacted by this issue.The lots listed in this mdr are the only in-date lots.This follow-up mdr is being sent to correct information previously sent in the initial mdr.Section h3.Device evaluated by manufacturer, section h6.Event problem and evaluation codes and section h11 corrected data have been updated to reflect the changes.Investigation to date into this issue has identified that carryover can occur from interaction of the gentamicin tracer into the hs troponin-i conjugate via r2 pipettor on the i2000sr and via the only pipettor on the i1000sr.This carryover has the potential to cause falsely elevated troponin results.A product correction letter has been issued to all customers who have received the architect igentamicin reagent kit.The product correction letter informs the customer of the issue with the architect igentamicin reagent and provides the customer with the necessary actions to take to mitigate the issue.

• Brand Name: ARCHITECT IGENTAMICIN
• Common Device Name: GENTAMICIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10020975
• Report Number: 3002809144-2020-00335
• Device Sequence Number: 14156321
• Product Code: LCD
• UDI-Device Identifier: 00380740001742
• UDI-Public: 00380740001742
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2020
• Device Model Number: 1P31-25
• Device Catalogue Number: 01P31-25
• Device Lot Number: 04281BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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: 3002809144-04/29/20-003-
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I1000SR, LIST 01L86,; ARCHITECT I1000SR, LIST 01L86,; ARCHITECT I2000SR, LIST 03M74; ARCHITECT I2000SR, LIST 03M74