MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STAT SENSOR CREAT-TEST STRIPS; STATSENSOR

Model Number 43370

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint sample has not returned to nova as of yet; therefore, an evaluation of the device could not be performed.Further investigation is being completed and a supplemental report will be submitted upon completion.

Event Description

The customer reports discrepant creatinine results.The patient did not have a pre-scan intravenous hydration done and was retested.There was no patient injury, harm, or additional treatment provided.

Manufacturer Narrative

Udi: (b)(4).As reported by the customer, there were discrepant creatinine results.The complaint sample for the meter s/n: 47034716229 was returned for evaulation.The returned statsensor strips, lot # 4920104129, were mistakenly discarded upon receipt by nova.However, it was determined that testing of returned strips would have been useless as they were not shipped back in a cooler.Statsensor test strips are refrigerated product.Testing of retained statsensor creatinine test strips, lot# 4920104129 and returned statsensor meter sn 47034716229, met the performance acceptance criteria for linearity solutions and whole blood samples and no discrepant values were obtained.The conclusion of this investigation is that the discrepant creatinine result issue reported could not be reproduced.No patient impact was reported.Nova will continue to monitor for recurrence and no further action is required at this time.

Manufacturer Narrative

Additional and corrected information: b4, d10, g7, h2, h4, h6, h10.The complaint sample for the meter s/n: (b)(6) was returned on (b)(6) 2020, for evaluation.The evaluation is currently underway and upon completion of this investigation and the testing of the retain strips, statsensor creatinine test strips, lot# 4920104129, a final report will be provided.A dhr review was conducted for the statsensor creatinine test strips, lot# 4920104129.Device history record (dhr) reviews for the statsensor creatinine test strips, lot# 4920104129 and statsensor creatinine meter, s/n (b)(6) were performed by the quality engineer on (b)(6) 2020.The review included an assessment of the production, testing and release of the meter and test strip batch.No abnormalities or concerns were observed; the dhr indicated that the released product met all specifications.

• Brand Name: STAT SENSOR CREAT-TEST STRIPS
• Type of Device: STATSENSOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham, ma
• MDR Report Key: 10082688
• MDR Text Key: 199545763
• Report Number: 1219029-2020-00037
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 10385480433706
• UDI-Public: 10385480433706
• Combination Product (y/n): N
• PMA/PMN Number: K171059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 43370
• Device Catalogue Number: 43370
• Device Lot Number: 4920104129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 78