MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT I2000SR ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number 03M74-02

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

The account stated one patient generated inconsistent cyclosporine results when processed on the architect i2000sr analyzer.A 9:00am draw time sample generated an architect cyclosporine result of 231 ng/ml which was questioned by the physician.The sample was rerun with architect cyclosporine results of 116, 117 and 159 ng/ml.The specimen was repeated at another lab with cyclosporine of 118 ng/ml.A 1:00pm draw time sample from the same patient generated an architect cyclosporine of 356 ng/ml, but reference lab result of 254 ng/ml.The reference lab result of 254 ng/ml was reported out of the laboratory.No impact to patient management was reported.

Manufacturer Narrative

(b)(4).A followup report will be submitted when the evaluation is complete.Evaluation in process.

Manufacturer Narrative

Sample rerun result of 117 ng/ml was not generated by the account and was a typographical error.A field service representative replaced the r1 pipettor and calibrated the sample, r1, and r2 probes.The service history for this instrument revealed no subsequent complaints of discrepant/erratic results were reported.A review of similar complaints for erratic results did not identify an adverse trend of the probe or i2000sr analyzer.The architect system operations manual addresses troubleshooting of the described issue and the cyclosporine package insert addresses sampling handling and performance characteristics.A single definitive cause was not identified.An issue with sample handling/integrity could not be ruled out as the issue was isolated to a single patient sample tested.The field service representative calibrated the sample, r1, and r2 probes to resolve the result issue.The architect i2000sr analyzer is performing acceptably.

• Brand Name: ARCHITECT I2000SR ANALYZER
• Type of Device: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 4911101
• MDR Text Key: 6032538
• Report Number: 1628664-2015-00200
• Device Sequence Number: 0
• Product Code: LTB
• Reporter Country Code: US
• PMA/PMN Number: K983212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03M74-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOT UNKNOWN
• Patient Age: 42 YR