MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HBSAG CONF; PRISM HBSAG CONFIRMATORY

Catalog Number	06E51-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that suspected (b)(6) confirmatory results were generated.A sample was initially tested with prism hbsag on (b)(6) 2016 and a (b)(6) result of (b)(6) was generated.The sample was repeated in duplicate and (b)(6) results of (b)(6) were generated.Prism hbsag confirmatory testing was performed on (b)(6) 2017 and a nonconfirming result was generated with a (b)(6) and a % neutralization of -30.17.The customer inadvertently performed confirmatory testing again on (b)(6) 2017 and a confirmed (b)(6) result was generated with a (b)(6) and a % neutralization of 67.03.No further testing was performed on the sample.The sample was from a first time donor that had received the (b)(6) 18 months prior.There was no report of adverse impact to patient management.
Additional Manufacturer Narrative
Field data for abbott prism hbsag lot 67099m500 was evaluated.A total of 2,217,127 samples were tested across multiple customer sites and the initial and repeat reactive rates were 0.04% and 0.01%, respectively, which are less than the abbott prism hbsag package insert upper 95% confidence intervals of 0.09% and 0.06%.The lot is meeting labeling claims for clinical specificity.A review of the device history records for the likely cause lot did not reveal any issues related to the customer's observations.Customer complaint data was reviewed and no adverse trends were identified.The prism hbsag and prism hbsag confirmatory reagent package inserts were reviewed and were found to adequately address the issue.The investigation did not identify a product deficiency.

• Brand Name: PRISM HBSAG CONF
• Common Device Name: PRISM HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6347243
• Report Number: 1415939-2017-00014
• Device Sequence Number: 11009080
• Product Code: KSJ
• UDI-Device Identifier: 00380740062972
• UDI-Public: (01)00380740062972(17)170207(10)62001M500
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2017
• Device Catalogue Number: 06E51-68
• Device Lot Number: 62001M500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 04/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISM ANALYZER 06A36-04, SN (B)(4); PRISM HBSAG 06D19-68, LOT 67099M500