MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-G; IGG ANTI-HAV

Model Number	6L27-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information: correction/removal reporting number = 3002809144-11/08/19-011-r.The investigation into this issue is in process.A follow-up mdr will be submitted when the cause has been identified.A product recall letter was sent to all customers who have received shipment of the architect havab-g calibrator kit, lot 08219be00.The letter instructs the following: immediately discontinue use of the lot 08219be00 and to destroy any remaining inventory of the lot.Immediately contact customer support to order replacement material.Review the recall letter with their medical director or laboratory management and follow the laboratory protocol regarding the need for reviewing previously reported patient results.If any kits of this specific lot was forwarded to other laboratories, to notify that laboratory of the product recall and provide them a copy of the recall letter.
Event or Problem Description
Abbott laboratories has identified an issue during stability testing with the architect havab-g calibrator kit, list number 06l27-01; lot 08219be00, where this specific lot has the potential to be impacted by an increase in the relative light units (rlus) of up to 95%.With the increase in the calibrator rlu values, there is the potential for control values and patient results generated with the impacted calibrator lot to be decreased, which may change interpretations of results from reactive to falsely non-reactive.There has been no reported impact to patient management as a result of this issue.
Additional Manufacturer Narrative
Complete information for : correction/removal reporting number = 3002809144-11/08/19-011-r.The investigation into the issue showed that the source of the elevated results on the tested samples was attributed to a contamination of the havab-g calibrator with (b)(6) anti-hcv calibrator, containing anti-hav igg.This resulted in elevated rlu of the specific calibrator vial.

• Brand Name: ARCHITECT HAVAB-G
• Common Device Name: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9376289
• Report Number: 3002809144-2019-00825
• Device Sequence Number: 3078368
• Product Code: LOL
• UDI-Device Identifier: 00380740011161
• UDI-Public: 00380740011161
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113704
• 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,Followup
• Report Date (Section B): 02/27/2020

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: 07/25/2020
• Device Model Number: 6L27-01
• Device Catalogue Number: 06L27-01
• Device Lot Number: 08219BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002809144-11/08/19-011-
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I1000SR, LN 01L86; ARCHITECT I1000SR, LN 01L86; ARCHITECT I2000SR, LN 03M74; ARCHITECT I2000SR, LN 03M74