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

Model Number 100071

Device Problem Low Test Results (2458)

Patient Problem Lethargy (2560)

Event Date 01/02/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, a phone call was received from the customer's daughter alleging discrepant low inratio inr results in comparison to the laboratory inr result.On (b)(6) 2015, the inratio inr was 2.5 and on (b)(6) 2015, the inratio inr was 2.0.There was no dosage changes made during this time.The customer's therapeutic range was 1.9 - 2.3.On (b)(6) 2015, the inratio inr was 2.3.The daughter reported that the customer was not "really" responding that day and was very sleepy , therefore, she was taken to the hospital.The laboratory inr at the hospital was 7.0.The customer was hospitalized for elevated blood sugar, elevated inr, dehydration and staph infection.Treatment included holding of warfarin, intravenous (iv) therapy and antibiotic (cefzil) for five (5) days.The customer was discharged from the hospital on (b)(6) 2015 and the warfarin was held until (b)(6) 2015.The daughter was unable to provide further details regarding treatment, hospitalization or inratio pt/inr test strip lot number that was used.Additionally, the daughter reported that on (b)(6) 2015, the customer's inratio inr was 5.3 and warfarin was held.The following day, (b)(6) 2015, the inratio inr was 1.9 and six (6) hours later the inratio inr was 1.4 and the laboratory inr was 1.0.The inratio pt/inr test strip lot number used was 355822.There was no additional information provided.

Manufacturer Narrative

The inratio pt/inr test strips lot #355822 is being reported under a separate manufacturer report number 2027969-2015-00125.Investigation pending.

Manufacturer Narrative

Investigation/conclusion: the monitor associated with the complaint was returned for investigation.The customer did not provide a lot number at the time of the complaint.Upon reviewing the returned monitor's memory, it was determined that in the month ((b)(6)) of reported complaint, the customer utilized strip code vb8ad which corresponds to strip lot# 355401.Since lot# 355401 was depleted, lot# 355402 was utilized for the investigation.Lot#355402 is identical to 355401 except for the outer packaging and labeling.The complaint was not confirmed during in-house investigation.Investigation of the returned monitor using retain strips did not uncover any deficiencies.The monitor and strips continue to meet specification and no product deficiencies were observed.The manufacturing records for lot# 355402 were reviewed.The lot met specifications and no relevant non-conformances were documented.Investigation of the returned monitor resulted in successful passing of functional testing, but failed in thermistor heater plate testing.Thermistors a and b both failed to meet specification.Because the heater plate thermistors failed to meet specification, (b)(4) was opened.Statistical analysis of testing performed as part of an extended complaint failure investigation (reference (b)(4)) 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.The customer's inratio inr values of 2.5, 2.0 and 2.3 were present in the monitor memory; however the dates of correspondence were different.Because the inr values were not present in the last 4 results, the impedance curve analysis could not be analyzed for characteristics of a weak-slope change.An impedance curve with a weak-slope change has been identified in capa investigation (capa-(b)(4)), to contribute to a potential discrepant result.In addition, capa-(b)(4) has determined that certain relevant conditions (e.G.Low hematocrit, sepsis) can contribute to discrepant inr results.The patient was reported to have a staph infection which as been identified as a condition that may contribute to a discrepant inr result.A notification letter has been sent to customers to inform them of these patient conditions.The root cause is unable to be determined.Further investigation is being performed under capa-(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 (Section G): 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: 4532550
• MDR Text Key: 5511194
• Report Number: 2027969-2015-00124
• 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: Other,Consumer
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/11/2015

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2015
• 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
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: CLARITIN AS NEEDED; METFORMIN; OXYBUTYNIN; PROTONIX; DIPHENOXYLATE; INRATIO MONITOR SN (B)(4); WARFARIN 4MG
• Patient Outcome(s): Hospitalization; Required Intervention