MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 200432

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problems Vomiting (2144); Chills (2191)

Event Date 05/13/2015

Event Type  Injury  

Event Description

The customer reported a variance between the inratio inr result and the laboratory inr result (no actual result provided).On (b)(6) 2015, the customer tested on the inratio device and received an inr of 2.4 and a "lo" error message.Her therapeutic range was 2.5 - 3.5.The same day, the experienced vomiting and chills; therefore, went to the emergency room.Magnetic resonance imaging (mri) at the hospital showed a blockage to her liver duct which required surgery.The laboratory inr was "too high" for surgery (no actual result provided and none was able to be obtained from the physician/facility).The customer was administered vitamin k and potassium, to lower her inr, and waited fifteen (15) hours before the surgery/procedure could be performed.The customer was discharged from the hospital on (b)(6)2015.Although the hospital laboratory result was reported as "too high" for surgery, it does not necessarily mean that the actual laboratory result was extremely high.It means that the result was higher than what the physician was comfortable with to perform the surgery/procedure, due to the risk of bleeding.Since it cannot be determined, what the actual laboratory inr was, it will be assumed that the inr was actually high.Attempts have been made to obtain additional information, however, none was provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation/conclusion: the monitor associated with the complaint was returned for investigation.The strips associated with the complaint were not returned.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer's complaint of a discrepant low result was not replicated during in-house investigation.The release specification is within the calculated confidence interval of the percent flier rate for the complaint investigation testing.There was no product deficiency found for lot 360632.The returned monitor met functional and thermistor testing requirements during investigation.The monitor memory was reviewed.The customer's inratio inr result of 2.4 was found in the memory on (b)(6) 2015 and not on the reported date of occurrence of (b)(6) 2015.The impedance curve of the customer's result of 2.4 was statistically analyzed and exhibited a weak slope change.Our capa investigation (capa-(b)(4)) has determined that impedance curves with weak slope that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to weak slope change impedance curves.There was no patient conditions provided by the customer to determine if these led to the weak slope change observed.Further investigation is documented under capa-(b)(4).

Manufacturer Narrative

The monitor associated with the complaint was returned for investigation.The strips associated with the complaint were not returned.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer's complaint of a discrepant low result was not replicated during in-house investigation.The release specification is within the calculated confidence interval of the percent flier rate for the complaint investigation testing.There was no product deficiency found for lot 360632.The returned monitor met functional and thermistor testing requirements during investigation.The monitor memory was reviewed.The customer's inratio inr result of 2.4 was found in the memory on (b)(6) 2015 and not on the reported date of occurrence of (b)(6) 2015.The impedance curve associated with the discrepant result of 2.4 was statistically analyzed and exhibited a weak slope change.An impedance curve with a weak slope change has been identified in capa-(b)(4) as a contributing factor to a potential discrepant result.Capa investigation (capa-(b)(4)) has determined that certain relevant conditions can contribute to discrepant inr results.The patient was reported to have had an infection in the liver duct.This capa has identified acute infections as a medical conditions that may contribute to a discrepant inr result.A medical device correction letter (december 2014 recall) has been sent to customers to inform them of these patient conditions.Further investigation is documented under capa-(b)(4).

Event Description

After the procedure, the patient reported that an infection was found in her liver duct.No additional information was provided.

• Brand Name: INRATIO2 PT MONITORING SYSTEM
• 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: 4838834
• MDR Text Key: 5872385
• Report Number: 2027969-2015-00392
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2015

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: 200432
• Device Lot Number: 360632
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 06/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/17/2015; 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: HYDROCHLOROTHIAZIDE; OTHER UNSPECIFIED MEDICATIONS; INRATIO MONITOR SN (B)(4); WARFARIN 5 MG; TIROSINT; PEPCID; LIPITOR
• Patient Outcome(s): Hospitalization; Required Intervention