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

Lot Number	4233970
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Renal Failure (2041); Dizziness (2194); Coma (2417)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017 the lay user/patient contacted lifescan alleging that their onetouch ultramini meter was reading inaccurately erratic.The customer care advocate (cca) attempted to contact the patient with follow up questions from medical surveillance but they were unable to reach the patient.The following complaint was classified based on information obtained from the original cca documentation.The patient alleged that the product issue began at 1:59pm on (b)(6).The patient reported obtaining blood glucose readings of 290, 484 and 544mg/dl on the subject meter.Lifescan could not confirm the timing of these readings as we were unable to reach the patient.The patient manages their diabetes with a combination of medication but they were unable to provide further details.The patient reported developing symptoms of ¿dizziness, went into a coma and kidneys shut down¿.The patient reported being treated at the emergency room at 5:30pm on (b)(6).The patient did not provide further details of the treatment received.Lifescan were unable to confirm if the reported coma was associated with an acute blood glucose excursion.At the time of troubleshooting the cca noted that the patient did not take the reported readings from the same approved sample site.Replacement products were sent to the patient.This complaint is being reported because the patient may have developed signs and/or symptoms suggestive of a serious injury adverse event after the alleged issue began.

• Brand Name: OT ULTRAMINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 6978962
• Report Number: 3008382007-2017-22963
• Device Sequence Number: 19139560
• Product Code: NBW
• UDI-Device Identifier: 00353885002684
• UDI-Public: (01)00353885002684
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: 4233970
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/06/2017
• Device Age: 9 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 120