MAUDE Adverse Event Report: UNKNOWN IV ASCORBIC ACID; ACID, FOLIC, RADIOIMMUNOASSAY

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

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  No Answer Provided  

Event Description

Actual error: no.Not necessarily an error per se but worth sharing."covid-19 patient with history of diabetes started on iv ascorbic acid.Became hyperglycemic after starting, requiring insulin drip.(b)(6) notified provider that iv ascorbic acid can cause misreading's of glucose measurements so it was stopped.Patient then became hypoglycemic requiring dextrose infusion." my understandings that there is some sort of reaction between the test strips of beside glucose meters and iv ascorbic acid, which results in falsely elevated glucose levels: gtt titrations or correctional scale insulin administration.Still researching best practices/brainstorming solutions - if poc blood glucose > 200, draw lab for confirmation? or convert iv ascorbic acid to po when patient needs an insulin infusion? problem is that bioavailability drops to ~33% with doses 1250 mg per lexicomp, so not sure conversion to po is feasible in bum patients (or even sepsis patients?).Fyi there is a webinar on this topic next thursday: (b)(6).Medication administered to or used by any patient: no.Patient counseling provided: unknown.Relevant materials: none.(b)(6).

• Brand Name: IV ASCORBIC ACID
• Type of Device: ACID, FOLIC, RADIOIMMUNOASSAY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10270316
• MDR Text Key: 198955255
• Report Number: MW5095515
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1