MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC PRISM 6 CHANNEL ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number 06A36-04

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2015

Event Type  malfunction  

Event Description

The customer observed (b)(6) combo results while using the prism reaction trays on the prism 6 channel ce analyzer.The customer indicated that a plasma sample generated the following (s/co): (b)(6) 2015: initial 2.74 (reactive); (b)(6) 2015: retest 1.26 (b)(6), retested 0.31 (b)(6).There was no adverse impact to patient management reported.No additional patient information has been provided.

Manufacturer Narrative

(b)(4).A follow-up report will be submitted when the evaluation is complete.An evaluation is in-process.

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint text, in-house testing, batch record review, a search for similar complaints, and a review of product labeling.Return material was not available.A clinical specificity testing protocol was executed using the reaction tray lot in question with the prism (b)(6) combo assay.Testing met the acceptance criteria and determined the products are meeting expected specificity requirements and are performing acceptably.No issues were identified from the batch record review which would indicate a product deficiency.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the prism 6 channel analyzer, list number 6a36, was identified.

Manufacturer Narrative

A second (b)(4) ag/ ab combo lot number was added to the conconitant medical products field.An evaluation is in-process.

Event Description

On 03/17/2015 additional information was provided by the customer.The customer indicated that a plasma sample generated the following (b)(6) results while using the prism reaction trays on the prism 6 channel ce analyzer (s/co): 02/16/2015: (b)(6).There was no adverse impact to patient management reported.No additional patient information has been provided.

• Brand Name: PRISM 6 CHANNEL 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: 4551107
• MDR Text Key: 5512093
• Report Number: 1628664-2015-00089
• Device Sequence Number: 1
• Product Code: NHS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970042
• 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,Followup
• Report Date: 02/06/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 06A36-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/10/2015; 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/1996
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6) COMBO REAGENT; LN 07G46-48, LOT 45743LI00; (B)(6) COMBO REAGENT; LN 07G46-48, LOT 43996LI00; LN 07G46-48, LOT 45743LI00