MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HIV O PLUS; HIV-1 AND HIV-2 ANTIBODIES

Catalog Number 03L68-68

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

The customer observed (b)(6) results that do not confirm for blood donors on the prism analyzer.Data was provided showing their repeat (b)(6) rate is below (b)(6), but higher than (b)(6) data.(b)(6) donors are (b)(6).Per the prism (b)(4) package insert: repeatedly reactive results indicate the presence of (b)(6) by the criteria of the abbott prism (b)(4) assay.There was no impact to patient management reported.

Manufacturer Narrative

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

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling and specificity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Specificity testing on a representative lot met all specifications.Complaint data review by lot and device history record review could not be performed since the suspect medical device lot is unknown.However, review of the prism metrics field data from january - august 2014 indicates that the product is meeting labeling claims for clinical specificity.Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.

• Brand Name: PRISM HIV O PLUS
• Type of Device: HIV-1 AND HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• 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: 4213355
• MDR Text Key: 5042268
• Report Number: 1415939-2014-00228
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03L68-68
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LN 06A36-04, SN (B)(4); PRISM ANALYZER:; PRISM ANALYZER:; LN 06A36-04, SN (B)(4)