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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP OZO

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP OZO Back to Search Results
Model Number MMT-551NAS
Device Problem Insufficient Information (3190)
Patient Problems Hypoglycemia (1912); Overdose (1988)
Event Date 08/17/2015
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We, therefore, consider this report complete to the best of our knowledge. (b)(4).

 
Event Description

A diabetes clinical manager called in to report for the customer of a hospitalization due to low blood glucose levels and a car accident. The customer's blood glucose level was 29 mg/dl. The cause per the healthcare provider was that the customer accidentally over bolused. The customer was not yet released from the hospital but was doing better and would be released soon. The product was not replaced or returned for analysis.

 
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Brand Name530G INSULIN PUMP
Type of DeviceOZO
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key5065606
MDR Text Key25319565
Report Number2032227-2015-41428
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
PMA/PMN Number120010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/09/2015
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-551NAS
Device Catalogue NumberMMT-551NAS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/09/2015 Patient Sequence Number: 1
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