MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP; GLUCOSE OXIDASE, GLUCOSE

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

Patient Problems Therapeutic Effects, Unexpected (2099); Test Result (2695)

Event Date 05/31/2019

Event Type  No Answer Provided  

Event Description

Patient (pt) had risk factors to do blood sugar (bs) test.Pt's mother was on insulin drip until approx.1 hour before delivery.Bs done with floor glucose monitor @ 1031- 20.1034-22.Pediatrician stated to not treat low bs until she came to assess baby and requested to do serum bs.Glucose gel given to baby as ordered after blood drawn.Results discrepancy noted when comparing blood glucose monitor with serum bs-41 @1110.Mother of infant on insulin drip until 1 hour before delivery, 0930 infant breastfed for 20 minutes, 1030 point-of-care testing (poct) infant blood glucose 20, 1049 called to nurse practitioner (np) to notify of low blood glucose, 1055 np orders serum blood glucose, then treat with oral glucose, 1057 np at bedside to assess infant, 1110 serum blood glucose 41, 1209 transferred to nursery, 1220 poct infant blood glucose 70.The difference in glucose levels is significant, however, some time passed between tests which could have given the infant more time to metabolize the breastmilk and raise its blood glucose as well as more time to regulate its own insulin after delivery, despite the insulin drip its mother was receiving.This is the only instance that has been reported regarding a discrepancy in glucose testing.Suggest continue to monitor for further discrepancies.

• Brand Name: STATSTRIP
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; prospect st; waltham MA 02454
• MDR Report Key: 9990225
• MDR Text Key: 188660704
• Report Number: 9990225
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2020
• Date Report to Manufacturer: 04/23/2020
• Type of Device Usage: N
• Patient Sequence Number: 1