MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-84
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results for three patients.The following data was provided (customer¿s reference range is 0.00-0.028 ng/ml): sample id m initial result, on (b)(6), was 0.034, repeat was 0.027 ng/ml; patient was redrawn on (b)(6), and the result was 0.14 ng/ml sample id a initial result, on (b)(6), was 0.034, repeat was <0.010, sample was recentrifuged and the repeat result was 0.019 ng/ml; patient was redrawn on (b)(6), and the result was 0.024 ng/ml.Sample id m and a were sent to a reference lab with an architect analyzer and the results were all <0.010 ng/ml.The customer recalibrated the probe, ran calibration and qc, and the repeat results for sample ids m and a were <0.010 ng/ml.Sample id g initial result, on (b)(6), was 0.042, repeat was 0.013 ng/ml; customer put on a new reagent pack and the result was 0.025, repeat was <0.010 ng/ml; patient was redrawn, and the result was 0.016, repeat was <0.010 ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = sample id m, sample id a, and sample id g.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
An abbott field service representative (fsr) was dispatched due to the customer reporting falsely elevated architect stat troponin-i results on the architect i1000sr, serial number (b)(6).Through an extensive investigation, the fsr found the pm sensor, tested, short cable, part number a-204217-02, and syringe assy, part number 7-77650-09, needed to be replaced, which resolved the customer¿s complaint.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency was identified.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results for three patients.The following data was provided (customer¿s reference range is 0.00-0.028 ng/ml): sample id m initial result, on (b)(6) , was 0.034, repeat was 0.027 ng/ml; patient was redrawn on (b)(6) , and the result was 0.14 ng/ml.Sample id a initial result, on (b)(6) , was 0.034, repeat was <0.010, sample was recentrifuged and the repeat result was 0.019 ng/ml; patient was redrawn on (b)(6) , and the result was 0.024 ng/ml.Sample id m and a were sent to a reference lab with an architect analyzer and the results were all <0.010 ng/ml.The customer recalibrated the probe, ran calibration and qc, and the repeat results for sample ids m and a were <0.010 ng/ml.Sample id g initial result, on 29jul, was 0.042, repeat was 0.013 ng/ml; customer put on a new reagent pack and the result was 0.025, repeat was <0.010 ng/ml; patient was redrawn, and the result was 0.016, repeat was <0.010 ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
It was discovered on august 30, 2023 that the initial and supplemental emdr for this issue were submitted under the correct suspect medical device, but incorrect manufacturer name, city, and state.Emdr number 3016438761-2023-00486-00 has been submitted for the correct manufacturing site and all further information will be documented under that emdr.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results for three patients.The following data was provided (customer¿s reference range is 0.00-0.028 ng/ml): sample id m initial result, on 27jul, was 0.034, repeat was 0.027 ng/ml; patient was redrawn on 28jul, and the result was 0.14 ng/ml.Sample id a initial result, on 27jul, was 0.034, repeat was <0.010, sample was recentrifuged and the repeat result was 0.019 ng/ml; patient was redrawn on 28jul, and the result was 0.024 ng/ml.Sample id m and a were sent to a reference lab with an architect analyzer and the results were all <0.010 ng/ml.The customer recalibrated the probe, ran calibration and qc, and the repeat results for sample ids m and a were <0.010 ng/ml.Sample id g initial result, on 29jul, was 0.042, repeat was 0.013 ng/ml; customer put on a new reagent pack and the result was 0.025, repeat was <0.010 ng/ml; patient was redrawn, and the result was 0.016, repeat was <0.010 ng/ml.There was no impact to patient management reported.

• Brand Name: ARCHITECT I1000SR
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17577350
• Report Number: 1628664-2023-00007
• Device Sequence Number: 12817757
• Product Code: JJE
• UDI-Device Identifier: 00380740116941
• UDI-Public: 00380740116941
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2023

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 Catalogue Number: 01L86-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2023
• Supplement Date Received by Manufacturer: 08/23/2023; 08/30/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 08/24/2023; 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC TROP RGT, 02K41-27, (B)(6) ; ARC TROP RGT, 02K41-27, (B)(6) ; ARC TROP RGT, 02K41-27, (B)(6)
• Patient Sex: Unknown