MAUDE Adverse Event Report: MICROGENCS CORPORATION VANCOMYCIN; RADIOIMMUNOASSAY, VANCOMYCIN

Model Number	6E44-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Nausea (1970); Tachycardia (2095)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, thermo fisher scientific was informed by a distributor that a patient receiving vancomycin showed questionable laboratory results for drug monitoring.A complaint was opened and stated that "the physician believes that level could have reached toxicity because the patient started to have toxicity symptoms after the last dose".All samples run on the vancomycin assay reported results of < 1.1 ug/ml.In the limitations of the procedure reported in the ifu state that in rare cases patient samples may contain heterophile antibodies which may produce low results with the multigent vancomycin assay.When samples were analyzed using a heterophile antibody blocking tube, values as high as 52.1 ug/ml were reported.The therapeutic range of vancomycin is 20-40 ug/ml.This indicates that the patient had heterophile antibodies present.
Additional Manufacturer Narrative
The complaint id for this issue is (b)(4).

• Brand Name: VANCOMYCIN
• Common Device Name: RADIOIMMUNOASSAY, VANCOMYCIN
• Manufacturer (Section D): MICROGENCS CORPORATION; 46500 kato road; fremont CA 94538
• Manufacturer Contact: jason erickson ; 46500 kato road; fremont, CA 94538 ; 5103810931
• MDR Report Key: 15920265
• Report Number: 3010939897-2022-00002
• Device Sequence Number: 19920250
• Product Code: LEH
• UDI-Device Identifier: 00380740009847
• UDI-Public: 00380740009847
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2023
• Device Model Number: 6E44-21
• Device Catalogue Number: 06E44-21
• Device Lot Number: 48721FD01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown