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 Type  malfunction  

Event Description

The customer observed (b)(6) results while using the (b)(6) on the prism 6 channel analyzer.The customer indicated that 24 specimens, which had been initial and (b)(6), were (b)(6) when tested using the western blot method.There was no adverse impact to patient management reported.No additional patient information has been provided.

Manufacturer Narrative

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

Manufacturer Narrative

The device manufacture date has been provided in this follow-up report.

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint text, review of data provided by the customer, in-house testing, batch record review, a search for similar complaints, and a review of product labeling.Return material was not available.The review of the customer data indicated that the initial and repeat reactive rates are within ranges of the specificity performance listed in the prism hcv package insert.The concomitant assay was also evaluated; a specificity testing protocol was executed in-house using lot 45613li00; testing met the acceptance criteria and determined the reagent is performing acceptably.No issues were identified, that related to the complaint under investigation, from the batch record review.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-ce analyzer, list number 6a36, was identified.

• 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: 4812269
• MDR Text Key: 17205079
• Report Number: 1628664-2015-00174
• Device Sequence Number: 1
• Product Code: MZA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: BK970042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• 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
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LN 06A52-48, LOT 45613LI00