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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALL MEDICUS CO. LTD EMBRACE PRO GLUCOSE TESTING READER AND PUNCTURE DEVICE; GLUCOSE OXIDASE, GLUCOSE
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ALL MEDICUS CO. LTD EMBRACE PRO GLUCOSE TESTING READER AND PUNCTURE DEVICE; GLUCOSE OXIDASE, GLUCOSE Back to Search Results
Model Number AGM 4000
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Hyperglycemia (1905)
Event Date 09/11/2018
Event Type  Injury  
Event Description
(b)(6) 2018 until (b)(6) 2018 when i got another new glucometer.The other new glucometer embrace pro gave faulty high glucose readings while i am on tpn causing excess insulin to be given and several lab tests to be performed unnecessarily.The readings were as high as 335 which caused 10 units of humulin r to be injected.The false readings were causing insulin to be injected in the tpn and then again in me daily for a month which were not needed.These false readings caused excessive unneeded lab tests to be performed to check my pancreas, etc.New glucometer shows levels on tpn to be in the low 100's.Lab tests also showed insulin in the 80's.Once labs were back, my internist suspected it was a faulty glucometer and he was correct.(b)(4).
 
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Brand Name
EMBRACE PRO GLUCOSE TESTING READER AND PUNCTURE DEVICE
Type of Device
GLUCOSE OXIDASE, GLUCOSE
Manufacturer (Section D)
ALL MEDICUS CO. LTD
5182 west 76th st
minneapolis MN 55439
MDR Report Key7999770
MDR Text Key125034415
Report NumberMW5080782
Device Sequence Number0
Product Code CGA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2018
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberAGM 4000
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
Patient Weight52
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