MAUDE Adverse Event Report: UNKNOWN DRIED BLOOD SPOT COLLECTION KIT; ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

Model Number UNKNOWN

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 05/09/2018

Event Type  malfunction  

Event Description

Took a dbs peth test on (b)(6) 2018.Result was positive, i did not consume nor was i exposed to alcohol.I was presented with attending 90 day inpatient rehab, or be terminated from my job.No medical review whatsoever.I had time appropriate follow on testing done that clearly indicates an anomaly, which also received no medical review.Distributed by (b)(4).Fda safety report id #: (b)(4).

Event Description

Additional information received for procode: dic.

• Brand Name: DRIED BLOOD SPOT COLLECTION KIT
• Type of Device: ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9977248
• MDR Text Key: 188690287
• Report Number: MW5094197
• Device Sequence Number: 1
• Product Code: DIC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White