MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HAVAB-M; IGM ANTI-HAV

Catalog Number	06L21-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported (b)(6) architect havab-m results on one patient.The results provided for the patient diagnosed with waldenstrom's macroglobulinemia: (b)(6).There was no additional patient information provided.There was no reported impact to patient management.
Additional Manufacturer Narrative
The customer observed erratic results for a patient diagnosed with waldenstrom's macroglobulinemia.A review of tickets determined that there were no additional complaints for lot 78085li00 and no trends were identified for the complaint issue.Historical performance of architect havab-m lot 78085li00 was evaluated using world wide data from abbott link.The overall median result across all lot numbers in the field during the reviewed timeframe is 0.18 s/co.The median patient result for lot 78085li00 is 0.17 s/co and indicates that the lot is performing in line with all other reagent lots.Manufacturing documentation for lot 78085li00 was reviewed and no contributing factors to the complaint could be identified.A review of labeling concluded that the issue is sufficiently addressed.Patients suffering from waldenstrom's macroglobulinemia show increased levels of monoclonal immunugobulins (usually igm) in the serum.Waldenstrom's macroglobulinemia belongs to the group of non-hodgkin's lymphomas and the architect havab-m reagent package insert states that specimens from individuals with non-hodgkin's lymphoma may cross-react with this assay.Based on the investigation no product deficiency was identified for architect havab-m, lot 78085li00.

• Brand Name: ARCHITECT HAVAB-M
• Common Device Name: IGM ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7150850
• Report Number: 3002809144-2017-00170
• Device Sequence Number: 1173903
• Product Code: LOL
• UDI-Device Identifier: 00380740011093
• UDI-Public: 00380740011093
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: 07/31/2018
• Device Catalogue Number: 06L21-25
• Device Lot Number: 78085LI00
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/14/2018
• 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: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4).; SERIAL # (B)(4).