MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT IVANCOMYCIN

Catalog Number	01P30-28
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2019
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.All available patient information was included.Additional patient details are not available.Patient identifier: sid's: 410619 and 410846.
Event or Problem Description
The customer reported a falsely decreased architect ivancomycin result on one patient.Results provided: 29sep2019 sid 410619 09/29/2019 = 1.36 / 26.47 / 25.15 ug/ml.New sample collected 4 hours later sid 410846 = 23.10 ug/ml.Normal range for vancomycin: (trough: 10 - 20 ug/ml; critical: >20 ug/ml).Initial result was reported out of the laboratory and questioned by the pharmacy as it did not line up with previous results; treatment had not been altered.Patient had been receiving vancomycin (initial specimen was a trough sample).Patient treatment was not provided based on the initial result.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of complaints determined that there are no trends for the product lot 07319a000 for the complaint issue.Return testing was not completed as returns were not available.Accuracy testing was performed to evaluate the performance of reagent lot 07319a000 and acceptance criteria was met, which indicates acceptable product performance.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect ivancomycin, lot 07319a000.

• Brand Name: ARCHITECT IVANCOMYCIN
• Common Device Name: VANCOMYCIN
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9224706
• Report Number: 3002809144-2019-00710
• Device Sequence Number: 1934855
• Product Code: LEH
• UDI-Device Identifier: 00380740105327
• UDI-Public: 00380740105327
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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 Catalogue Number: 01P30-28
• Device Lot Number: 07319A000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/01/2019
• 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 I1000SR ANALYZER LIST 01L86; ARCHITECT I1000SR ANALYZER LIST 01L86; SERIAL (B)(4).; SERIAL (B)(4).