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

Model Number 100071

Device Problems Device Expiration Issue (1216); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hemorrhage/Bleeding (1888); Dizziness (2194); Complaint, Ill-Defined (2331)

Event Date 10/15/2014

Event Type  Injury  

Event Description

Caller alleged discrepant results compared with the lab.Results as follows: date: (b)(6) 2014, inratio: 3.3; date: (b)(6) 2014, lab: 4.7; date: (b)(6) 2014, inratio 3.7.Therapeutic range = 2.5-3.5.Patient self tester admitted to hospital (b)(6) 2014 due to hemorrhage in intestinal track; she was extremely pale, light headed and overall not feeling well.Physician determined injury was hemorrhage through fecal test, chest x-ray, and other clinical symptoms.Patient self tester was given 2 pints of blood upon admission.Site of hemorrhage was not cauterized and no vitamin k was given; coumadin was held starting (b)(6) 2014; patient on lovenox from (b)(6) 2014.Patient is now at home doing well.It was noted that patient was using expired strips.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

The product associated with the complaint was returned for investigation.Therapeutic and normal donor testing was performed on the returned meter using retain strips.Because the customer utilized expired strips at the time of the reported discrepancy, lot number 331424 was chosen at random and was used for this investigation.The customer's complaint was not replicated during in-house investigation.However, during thermometer sensing on the unit, thermistor a failed to meet specification.Because the heater plate thermistor failed to meet specification further investigation into this issue is being pursued.The manufacturing records for lot number 310825 were reviewed.The lot met specifications and no non-conformances were documented.The lot met release specifications.The customer utilized expired inratio strips during testing.Use of the product beyond the expiration date can result in errors or inaccurate results.

Manufacturer Narrative

During thermometer sensing on the unit, thermistor a failed to meet specification.Statistical analysis of testing performed as part of an extended complaint failure investigation found there to be no significant difference in inr values between returned monitors that failed the heating specification with monitors that passed the heating specification.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4291115
• MDR Text Key: 5052634
• Report Number: 2027969-2014-01033
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 310825
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/26/2015; 03/19/2015
• 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
• Treatment: MONITOR: SN (B)(4); COUMADIN; LOVENOX; PROTONIX
• Patient Outcome(s): Hospitalization; Required Intervention