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

Model Number 6L27-25

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included. Additional patient details are not available. An evaluation is in process. A final report will be submitted when the evaluation is complete. On dec 19, 2019, this second suspect medical device was added. This event was previously reported in manufacturer report 3002809144-2019-00606.

Event Description

The customer observed (b)(6) results on the architect i2000sr analyzer when using a new lot of material. The following data was provided when comparing data between lots: (b)(6). There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling. No adverse trend was identified for the customer's issue. No return patient sample was available. Historical performance of the reagent lot was evaluated using world wide data. The patient data was analyzed and within expected limits. Labeling was reviewed and found to be adequate. Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

Manufacturer Narrative

Section b5. Describe event or problem: was updated to specify which lot generated which results. Section h4. Device manufacture date: was corrected from 07/2019 to 06/27/2019 complete information for section h9. Correction/removal number
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3002809144-03/16/20-002-r investigation into the issue confirmed a performance shift for the architect havab-g impacted reagent lots due to the erroneous concentration for hepatitis a virus that was utilized during manufacture, which has the potential to generate falsely elevated control and patient sample results. An internal study using anti-hav negative patient samples was conducted and determined that results that fall in the range of 1. 00 - 1. 72 s/co have the potential to be falsely reactive. A product recall letter has been issued to all customers who have received the impacted lots 03429be00, 06172be00, 08073be00, and 10353be00. The product recall letter instructs the customer to immediately discontinue the use of, and destroy, any remaining inventory of the specific 4- architect havab-g reagent lots and instructs the customer to contact customer support for replacement material in the event if they were currently using or have inventory of one of the impacted lots.

Event Description

The customer observed falsely elevated havab igg results on the architect i2000sr analyzer when using a new lot of architect havab-g reagent. The following data was provided when comparing data between lots: old lot (03429be00) 0. 90 to new lot (06172be00) 0. 55; old lot (03429be00) 0. 98 to new lot (06172be00) 0. 74; old lot (03429be00) 0. 81 to new lot (06172be00) 1. 01, repeated 0. 97, 1. 00. There was no impact to patient management reported.

• Brand Name: ARCHITECT HAVAB-G
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9501301
• Report Number: 3002809144-2019-01079
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (y/n): N
• PMA/PMN Number: K113704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/04/2020
• Device Model Number: 6L27-25
• Device Catalogue Number: 06L27-25
• Device Lot Number: 06172BE00
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3002809144-03/16/20-002-
• Patient Treatment(s): ARCHITECT I2000SR ANALYZER.; ARCHITECT I2000SR ANALYZER.; ARCHITECT I2000SR ANALYZER.; LN 03M74-02 SN (B)(6).; LN 03M74-02 SN (B)(6).; LN 03M74-02 SN (B)(6).