MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY I PROCESSING MODULE; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number 03R65-01

Device Problems False Negative Result (1225); Low Test Results (2458)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).An evaluation is in process.A followup report will be reported when the evaluation is complete.Evaluation is in process.

Event Description

The account discovered the inner reservoir trigger solution was empty on the alinity i processing module.The samples were processed again and observed (b)(6) and (b)(6) results.Id (b)(6) generated (b)(6) (0.0 au/ml) alinity i (b)(6) that repeated (b)(6) (119.47, 113.4 au/ml).Id (b)(6) generated (b)(6) alinity i (b)(6) (0.0 au/ml) that repeated (b)(6) (>250.0, 442.9, 469.8 au/ml).Id (b)(6) generated (b)(6) (0.0 iu/ml) alinity i (b)(6) that repeated (b)(6) (97.8 iu/ml).No specific patient information was provided.

Manufacturer Narrative

While troubleshooting the issue, it was discovered that the trigger solution was empty but the supply screen showed 66% trigger solution.Service replaced the alnty ci level sensr bu as the likely cause of the discrepant results.The issue was resolved.A review of the alinity i processing module serial (b)(4) service history verified no reports of discrepant results since the part was replaced.A review of the alinity i tracking and trending data in the product monitoring review revealed no systemic issues or adverse trends associated with the erratic result issue described in this complaint.A review of the reporting period and a 12- month search for similar complaints identified no adverse trends of the alnty ci level sensr bu.A review of the product labeling concluded that the issue is sufficiently addressed.Taken together, no product deficiency or systemic issue was identified.

Event Description

The account observed false negative cmv igg and toxo igg when processing on the alinity analyzer.Sid (b)(6) generated negative (0.0 au/ml) alinity i cmv igg that repeated reactive (119.47 / 113.4 au/ml); sid (b)(6) generated negative alinity i cmv igg (0.0 au/ml) that repeated reactive (>250.0 / 442.9 / 469.8 au/ml); sid (b)(6) generated negative (0.0 iu/ml) alinity i toxo igg that repeated reactive (97.8 iu/ml).The account also observed falsely depressed tsh results on a patient sample.Sid (b)(6) generated alinity i tsh <0.0083 miu/l that repeated 1.31 / 1.32 miu/l.No impact to patient management was reported.

Manufacturer Narrative

These events are associated with product correction fa07mar2019.Complete information for patient information.Patient identifier- multiple = sid (b)(6), a product correction letter was issued on 07mar2019 to all alinity i and alinity customers notifying them of the software and hardware issues on the alinity ci-series system.The product correction letter informs the customer that an abbott representative will schedule a mandatory upgrade of their alinity ci-series to software version 2.6.0 to resolve each of the identified issues and provide customers necessary actions until the mandatory upgrade is completed.Complete information for correction/removal number 3002809144-03/14/19-002-c.

• Brand Name: ALINITY I PROCESSING MODULE
• Type of Device: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7178547
• MDR Text Key: 97067686
• Report Number: 3002809144-2018-00002
• Device Sequence Number: 0
• Product Code: LGD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R65-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3002809144-03/14/19-002-
• Patient Sequence Number: 1
• Treatment: (B)(6) IGG LIST 07P42; (B)(6) IGG LIST 07P42, TOXO IGG LIST 07P45; ALINITY I (B)(6) IGG LIST # 07P42-22,; ALINITY I TOXO IGG LIST # 07P45-22,; ALINITY I TSH, LIST # 07P48-20; TOXO IGG LIST 07P45