MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT PING METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4305627

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

Patient Problems Fever (1858); Urinary Frequency (2275); Confusion/ Disorientation (2553)

Event Type  Injury  

Manufacturer Narrative

Other patient problem symptoms with no code - mental things, cough, dry throat, hallucination and sugar out of control.

Event Description

On (b)(6) 2018, the reporter for the patient contacted lifescan (lfs) alleging that her onetouch ultra ping meter read inaccurately high compared to another meter (precision exceed, hospital meter).The complaint was classified based on the customer care advocate (cca) documentation.The reporter stated that the alleged product issue first began about six weeks prior to contacting lfs and been ongoing.The reporter stated that on (b)(6) 2018 the patient obtained an alleged inaccurately high result of 311mg/dl on the subject meter compared to 183mg/dl on the other meter.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.The reporter was unwilling to say what medications the patient takes to manages her diabetes and reported that she ¿skipped medication from the pump¿ in response to the alleged product issue.The reporter stated that for the ¿past week¿ she was experiencing symptoms of ¿low grade fever, mental things, sugar out of control, dry throat, cough, urination and hallucination¿ after the alleged product issue began.The reporter was unwilling to state what treatment the patient received, only to say she received a ¿series of treatments¿.At the time of troubleshooting, the cca confirmed that the meter was set with the correct unit of measure at the time of testing and the sample was taken from an approved sample site.The correct testing steps were performed.The cca confirmed that the test strip vial was neither cracked nor broken.The test strips were stored correctly and within expiry date.The patient did not have control solution to perform a control solution test.The patient¿s products were replaced.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury adverse event after the alleged product issue began.

• Brand Name: OT PING METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7821700
• MDR Text Key: 118390790
• Report Number: 3008382007-2018-02386
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K082590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4305627
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/20/2018
• Device Age: 48 MO
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 80 YR
• Patient Weight: 59