MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; BLOOD GLUCOSE METER

Model Number 53398

Device Problem Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

There was no reported patient harm or intervention.There is currently a pending investigation.A request has been sent to the customer obtain meters and barcode or sample of a test barcode for verification of 1-d versus 2-d barcodes.Additional information and further details will be provided in a supplemental report.

Event Description

A customer reported that gluc conn meters (1.75) mis-scanning 1d bar showing incorrect patient id's.The account has 1 & 2 d bar codes on patients wrists.There has been no report of patient harm or adverse event.

Manufacturer Narrative

Additional and corrected information: b4, d9, g6, h1, h2, h3, h10.An investigation has been initiated and is currently pending.Further details will be provided in an additional supplemental report when they become available.

Manufacturer Narrative

The customer reported an incorrect account number shown when scanned by the statstrip 1.75 meter sn (b)(6).The meter scanned a patient identification number however; received incorrect output that did not match.The customer states they are unaware of any patient harm from the barcode misread and will not be returning the meter as it is currently in use at the facility.To date, the product has not been received for evaluation.Without the returned product a detailed investigation on the failed product could not be performed, and the reported condition could not be confirmed.The cause(s) of the difficulty reported by the customer could not be determined.A device history record (dhr) review for the statstrip meter sn (b)(6) was performed by a quality control engineer.The review included an assessment of the production, testing, and release of the products.No abnormalities or concerns were observed; the dhr indicated the released product met all specifications.Complaint will be closed as 'no complaint sample returned to nova for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.A capa (corrective and preventative action) is not required as a result of this investigation because the complaint was not confirmed.Nova will continue to monitor for recurrence, no further action is required at this time.

• Brand Name: NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• MDR Report Key: 11507402
• MDR Text Key: 243977195
• Report Number: 1219029-2021-00006
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00385480533980
• UDI-Public: 00385480533980
• Combination Product (y/n): N
• PMA/PMN Number: K063821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

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: 53398
• Device Catalogue Number: 53398
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 02/18/2021; 04/14/2021
• Supplement Dates FDA Received: 04/14/2021; 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1