MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT MYOGLOBIN CALIBRATORS; CALIBRATOR, PRIMARY

Model Number 2K43-01

Device Problem Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  malfunction  

Event Description

The customer reported that after the field service representative (fsr) was onsite and replaced parts on the architect i2000sr analyzer, the customer ran technopath quality control (qc) on myoglobin and noted that the results were out of range high per the package insert ranges while using the architect stat myoglobin calibrator, lot 166000.The fsr reviewed the data and found that the qc was in range but higher since service was performed on the instrument.It was also noted that the assay had not been calibrated since 11feb2022.The fsr recommended to the customer that the assay should be calibrated due to the parts being replaced during a previous service call.It was recommended to calibrate the assay and run 2 replicates of each level of controls; this resolved the customer issue.There was no reported impact to patient management.

Manufacturer Narrative

The investigation into this issue is in process.A follow-up report will be submitted when the investigation is complete.A product recall letter was sent to all customers who have received shipments of architect stat myoglobin calibrators ln 02k43-01, lot 166000.The product recall letter notifies the customer of the issue and the potential impact to patient results with use of the impacted lot.The product recall letter instructs customers to immediately contact customer support to order a replacement product and to discontinue use of and destroy any remaining inventory of lot 166000 according to their laboratory procedures.The evaluation remains in process.

Manufacturer Narrative

During the investigation into this issue, it was noted that an equilibrium shift seen in the architect myoglobin calibrator lot 166000; which was atypical compared to other historical lots.It was further determined that the architect myoglobin calibrator lot 166000 was not at dose/response equilibrium at the time of bulk s/c testing because the rlu performance determined at this stage was not conserved over time.The investigation also identified that calibration performance declined over time as a normal occurrence of calibrator stability.As calibrator rlu performance decreases over time, samples read off of it will trend upwards.Together these findings showed that the initial equilibrium shift combined with decreasing calibrator rlu stability performance existed for calibrator lot 166000, which that led to the stability failure.A product recall letter was sent to all customers who have received shipments of architect stat myoglobin calibrators ln 02k43-01, lot 166000.The product recall letter notifies the customer of the issue and the potential impact to patient results with use of the impacted lot.The product recall letter instructs customers to immediately contact customer support to order a replacement product and to discontinue use of and destroy any remaining inventory of lot 166000 according to their laboratory procedures.This supplemental mdr is being submitted to include the investigational findings for the issue.

• Brand Name: ARCHITECT STAT MYOGLOBIN CALIBRATORS
• Type of Device: CALIBRATOR, PRIMARY
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14416297
• MDR Text Key: 291852847
• Report Number: 1415939-2022-00037
• Device Sequence Number: 1
• Product Code: JIS
• UDI-Device Identifier: 00380740003272
• UDI-Public: 00380740003272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 2K43-01
• Device Catalogue Number: 02K43-01
• Device Lot Number: 166000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1415939-03/10/22-001-R
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR63007; ARC I2000SR INST, 03M74-02, ISR63007