MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

Patient Problems Overdose (1988); No Consequences Or Impact To Patient (2199)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio value.(b)(6).No additional information provided.No reported adverse patient sequela.

Manufacturer Narrative

Investigation/conclusion: the meter associated with the complaint was returned for investigation.Retained strips of the reported lot were tested because the customer's strips were not returned.Retained strips tested on the returned meter met accuracy criteria.The returned meter met functional and thermistor testing requirements during the investigation.The customer's complaint was not replicated during in-house testing and no product deficiencies were observed.The system performed as expected.A review of the entire in-house testing history for the reported lot was conducted.In-house testing on the reported strip lot meets release criteria.The manufacturing records for the lot were reviewed and the lot met release specifications.Impedance curve analysis could not be performed because the customer's reported result was not located in the meter memory.Root cause could not be determined from the information provided by the customer.

Manufacturer Narrative

Investigation/conclusion: update: the meter associated with the complaint was returned for investigation.Retained strips of the reported lot were tested because the customer's strips were not returned.Retained strips tested on the returned meter met accuracy criteria.The returned meter met functional and thermistor testing requirements during the investigation.The customer's complaint was not replicated during in-house testing and no product deficiencies were observed.The system performed as expected.A review of the entire in-house testing history for the reported lot was conducted.In-house testing on the reported strip lot meets release criteria.The manufacturing records for the lot were reviewed and the lot met release specifications.A review of the meter memory found an inratio inr result of 2.0 instead of the reported result of 2.2.A statistical analysis of the impedance curve for the result determined that the curve was normal in shape and did not exhibit weak slope change or curve abnormalities.Although technique issues were identified in the complaint, a root cause could not be determined from the information provided by the customer.(b)(4) was initiated to investigate the cause of highly discrepant results.Further investigation into this issue is being performed under (b)(4).

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5812393
• MDR Text Key: 51008448
• Report Number: 2027969-2016-00529
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2016

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: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 386291A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/26/2016; 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1