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

Catalog Number 03M74-02

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information, patient identifier - multiple are sid (b)(6).

Event Description

The customer stated that the architect analyzer generated falsely elevated afp results on two patients.The results provided were: sid (b)(6) on (b)(6) 2016 afp = 8.23 / 3.21; (b)(6) 2016 sid (b)(6) afp = 11.88 / 2.2ng/ml.There was no additional patient information provided.There was no reported impact to patient management.

Manufacturer Narrative

Evaluation of the customer issue included a review of: the complaint text, service history, trend reports, complaint searches, and product labeling.There was no patient sample provided to assist in the investigation.The complaint text indicated field service resolved the issue by cleaning a clogged wash zone 2 manifold (part number 7-96176-05) on (b)(6) 2016.The customer notified service of the discrepant results after the completion of the service visit.A review of the analyzer service history identified service tickets opened around the time of the results issue: (b)(6) 2016 concerns regarding wash aspirate monitoring alerts for wash zone 2, probe 2 and the temperature tubing/sensor was replaced; on (b)(6) 2016 error code 3350 [unable to process test, aspiration error for (sample pipettor) at (rv24)] and the sample probe was adjusted by the customer; lastly, on (b)(6) 2016 ec 3350 [unable to process test, aspiration error for (r2 pipettor) at (reagent carousel)] and the fsr replaced a syringe assembly.There have been no subsequent contacts from the customer regarding discrepant results since the wz manifold was cleaned and the adjustment/replacement of additional service parts identified above was performed.The architect system operations manual provides information including: troubleshooting and corrective actions to resolve ec 3350; and for observed problems / erratic results.The architect afp package insert provides information for assay processing, limitations of the procedure, performance characteristics and interpretation of results.A search for similar complaints identified no adverse trend of wz manifold in the past 12 months.A historic review of the architect i2000sr revealed no systemic issues or trends associated with erratic results.Based on the investigation performed, a malfunction was identified, however, no systemic issue or product deficiency of the instrument or part was identified.

• 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: 6248983
• MDR Text Key: 64737320
• Report Number: 1628664-2017-00008
• Device Sequence Number: 0
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• 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: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARCHITECT AFP, LIST # 03P36-30,; LOT # UNKNOWN