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 Consequences Or Impact To Patient (2199)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

The account generated (b)(6) prism hiv o plus results on 8 donor samples that tested (b)(6) western blot (b)(6) and (b)(6) nat (b)(6).The samples were from long time donors who were expected to generate (b)(6) results.No specific donor information provided.No impact to patient management was reported.Data provided of prism hiv o plus: (b)(6).

Manufacturer Narrative

(b)(4).A followup report will be submitted when the evaluation is complete.Evaluation in process.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause lot did not identify atypical activity.Additionally, a review of the device history record for the likely cause lot did not reveal any issues related to the customer's observations.Finally, a review of the prism metrics field data indicates that the initial and repeat reactive rates for the likely cause lot are less than the package insert upper 95% confidence intervals.No customer return product was available for evaluation.A review of the product labeling concluded that the issue is sufficiently addressed.As a result of this evaluation, no malfunction or 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: 4139420
• MDR Text Key: 4911154
• Report Number: 1415939-2014-00216
• 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: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 03L68-68
• Device Lot Number: 39519M501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM LIST 06A36-04; PRISM LIST 06A36-04; SERIAL (B)(4); SERIAL (B)(4)