MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ACTIVE-B12; ACTIVE B12

Catalog Number 03P24-25

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

The customer observed falsely elevated active b12 results on the architect i2000sr analyzer.The following data was provided (pmol/l): (b)(6), initial 13.5, repeats 58.9, 71.9, (b)(6), initial 95.7, repeats 51.5, 19.5, (b)(6), initial 19.8, repeats 34, 45.4.There was no impact to patient management reported.

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.(b)(4).An evaluation is in process.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling and review of historical data.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The customer observed an upward shift in external control results (patient samples were used as controls) with architect active-b12 reagent lot 10366up00.An analysis utilizing field data was completed to determine if the median patient values have shifted over time.The analysis showed that the median value has not changed over time and concluded that the reagent lots included in the analysis (including likely cause lot 10366up00) read patient results consistently.Also, a review of the certificate of analysis for the likely cause lot 10366up00 and the comparison lot 10351up00 found that both lots met all specifications.Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.

• Brand Name: ARCHITECT ACTIVE-B12
• Type of Device: ACTIVE B12
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 6520 5; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 6520 5; GM 65205
• 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: 4361614
• MDR Text Key: 20062995
• Report Number: 3002809144-2014-00199
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K112443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2015
• Device Catalogue Number: 03P24-25
• Device Lot Number: 10366UP00
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN (B)(4)