MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT IDIGOXIN

Catalog Number	01P32-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated digoxin (ln 1p32) result for one patient on the architect i2000sr analyzer.The following data was provided from (b)(6): sid (b)(6), initial 3.5 nmol/l.The doctor took the patient off digoxin for 2 weeks to monitor, yet the patient continued to have critically high levels of digoxin.On (b)(6): result: 3.5 nmol/l; at another hospital (on siemens analyzer) sample resulted as 0.2 nmol/l.On (b)(6): result: 3.2 nmol/l; at another hospital (unknown method) the sample resulted as 0.3 nmol/l.No other patient details were provided.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of the design history file, a review of labeling, accuracy testing and interference testing.No adverse trend, non-conformance, potential non-conformance, or deviations were identified for the customer's issue.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.An interference study was performed to determine if the drug xtandi (enzalutamide) interfered with the architect idigioxin assay.In samples absent of digoxin, the test results showed pseudo-digoxin was present at all concentrations.In measured concentrations of digoxin at 0.8 ng/ml and 2.0 ng/ml, cross reactivity was observed at 4mg/ml of enzalutamide for serum and k2-edta samples.Additionally, at 1mg/l of enzalutamide at both digoxin concentrations interference greater than 10percent was detected with serum samples.The idigioxin package insert has claims for interfering substances, however at the launch of the product, enzalutamide (xtandi) was not one of the interfering substances tested.The architect idigoxin reagent package insert will be updated to include enzalutamide interference and is being tracked through pcn cc16/550.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Additional Manufacturer Narrative
(b)(6) 2018 the test dates and sids were provided for the 3 samples from this patient sid (b)(6) tested (b)(6) 2018 sid (b)(6) tested (b)(6) 2018 sid (b)(6) tested (b)(6) 2018 the lot number was provided and changed from unknown to 00117k000.An evaluation is still in process.A follow up report will be provided when the evaluation is complete.

• Brand Name: ARCHITECT IDIGOXIN
• Common Device Name: IDIGOXIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7895367
• Report Number: 1415939-2018-00140
• Device Sequence Number: 19287433
• Product Code: KXT
• UDI-Device Identifier: 00380740001766
• UDI-Public: 00380740001766
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2019
• Device Catalogue Number: 01P32-25
• Device Lot Number: 00117K000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 10/10/2018; 10/15/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 10/11/2018; 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN (B)(4) ; LN 03M74-02 SN (B)(4) ; LN 03M74-02 SN (B)(4) ; ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN (B)(4)
• Outcome Attributed to Adverse Event: Other