MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT REALTIME HIV-1 AMP REAGENT KIT; TEST, HIV DETECTION

Model Number	6L18-90
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint ticket has been reviewed and has been determined to be the same issue as previously confirmed issue (b)(4).Complaint investigation (b)(4) included customer data review, product evaluation and complaint history review.Based on the results of the investigation elements a product deficiency for abbott realtime (b)(6) amp rgt kit-row (list (b)(4)) lot 476139 was identified.Specifically, based on in-house product evaluation file sample testing that verified the issue reported by the customer.Customer data review identified multiple error codes (error code 4440 - "positive control concentration is out of range", error code 4441 - "internal control cycle number is too low" and error code 4457 - "internal control failed") when reviewing customer run data and internal testing of retained file samples of lot 476139.The (b)(4) has been opened to investigate this issue.(b)(4) identified a second lot of amplification reagents exhibiting similar performance, and, as a result, u.S.Abbott realtime (b)(6) amplification reagent kit, list (b)(4), lot 475933 was also included in the scope of the investigation.As the root cause investigation is currently in progress, an interim action was initiated to evaluate whether additional lots were demonstrating the same performance issues.Based on the evaluation criteria of the interim action, a statistical process control (spc) analysis and timeframe of lots that were included and shared components a total of 14 lots have been included.Abbott molecular determined that a field corrective action ((b)(4)) should be taken and reported this issue per 21 cfr 806 to the fda (b)(6) recall coordinator on (b)(6) 2017 (report number 3005248192-08/01/2017-001-c).The field corrective action was in the form of a field correction recall letter / urgent field safety notice, dated (b)(6) 2017 instructing customers to discontinue use of and discard all remaining inventory of all realtime (b)(6) quantitative lots listed in the letter.Also included in the letter were considerations for healthcare providers as guidance for retesting (b)(6) viral loads of potentially impacted (b)(6) patients.The following mdrs were also reported: mdr 3005248192-2017-00003, mdr 3005248192-2017-00004, mdr 3005248192-2017-00005, mdr 3005248192-2017-00006, mdr 3005248192-2017-00007, mdr 3005248192-2017-00008, mdr 3005248192-2017-00009, mdr 3005248192-2017-00010, mdr 3005248192-2017-00011, mdr 3005248192-2017-00012, mdr 3005248192-2017-00013, mdr 3005248192-2017-00014, mdr 3005248192-2017-00015, mdr 3005248192-2017-00016, mdr 3005248192-2017-00017, mdr 3005248192-2017-00018, mdr 3005248192-2017-00019, mdr 3005248192-2017-00020, mdr 3005248192-2017-00021, mdr 3005248192-2017-00022, mdr 3005248192-2017-00023, mdr 3005248192-2017-00024, mdr 3005248192-2017-00025, mdr 3005248192-2017-00026, mdr 3005248192-2017-00027, mdr 3005248192-2017-00028, mdr 3005248192-2017-00029, mdr 3005248192-2017-00030, mdr 3005248192-2017-00031, mdr 3005248192-2017-00032, mdr 3005248192-2017-00033, mdr 3005248192-2017-00034, mdr 3005248192-2017-00035, mdr 3005248192-2017-00036, mdr 3005248192-2017-00037, mdr 3005248192-2017-00038, mdr 3005248192-2017-00039, mdr 3005248192-2017-00040, mdr 3005248192-2017-00041, mdr 3005248192-2017-00042, mdr 3005248192-2017-00043.
Event or Problem Description
The abbott realtime (b)(6) assay is an in vitro reverse transcription polymerase chain reaction (rt-pcr) assay for the quantitation of (b)(6) on the automated m2000 system in human plasma from (b)(6) infected individuals over the range of 40 to 10,000,000 copies/ml.The abbott realtime (b)(6) assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma (b)(6) rna levels.This assay is not intended to be used as a donor screening test for (b)(6) or as a diagnostic test to confirm the presence of (b)(6) infection.When running realtime (b)(6), (b)(4), lot 475933, customer reported they failed an (b)(6) run of 96 samples due to internal control failures on calibrator b.Complaint ticket has been reviewed via elevated complaint investigation (b)(4) and has been determined to be the same issue as previously confirmed via (b)(4) for reduced pcr amplification efficiency, which presents as delayed threshold cycle (ct) values and reduced max ratio (mr) values for both target and internal control across entire runs.Refer to section for a summary of original elevated complaint investigation (b)(4).The medical evaluation concluded that the hazards and harms identified in the malfunction risk evaluation (360-risk) would not be expected to cause or contribute to death or serious injury.This complaint is reported in accordance with 21 cfr 803 on the basis that a reportable (21 cfr 806) field action, (b)(4), was taken to address the issue.Refer to section for further information about the associated reportable field action.

• Brand Name: ABBOTT REALTIME HIV-1 AMP REAGENT KIT
• Common Device Name: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 6815089
• Report Number: 3005248192-2017-00044
• Device Sequence Number: 18864868
• Product Code: MZF
• UDI-Device Identifier: 00884999023949
• UDI-Public: (01)00884999023949(10)475933(17)180403
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BP060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/23/2017

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: No Information
• Device Expiration Date: 04/03/2018
• Device Model Number: 6L18-90
• Device Catalogue Number: 06L18-090
• Device Lot Number: 475933
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1