FDA.reportPublic FDA data

MAUDE MDR 9908906

MDR report key
9908906
Report number
3004209178-2020-92480
Event key
0
Event type
3
Date of event
2020-01-22
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
GERWIN DE GRAAFF
Address
CEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777 *
Phone
818-818-8185
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PUMP MMT-1780KPK 670G PATHWAY BLACK MGARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROLMEDTRONIC PUERTO RICO OPERATIONS CO.OZPMMT-1780KPKMMT-1780KPKHG2J0WPR R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

UNIT RECEIVED WITH BLEEDING LCD GLASS. UNIT ALSO RECEIVED WITH CORRODED ELECTRONIC ASSEMBLY DURING VISUAL INSPECTION. UNIT RECEIVED WITH CRACKED CASE(BATTERY TUBE), CRACKED BATTERY TUBE THREADS, MISSING SERIAL NUMBER LABEL, CRACKED RETAINER AND CRACKED KEYPAD AT SELECT BUTTON. (B)(4).

D

Patient 1

INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD A DAMAGED AND THE SCREEN AND CRACK ON THE BACK OF BATTERY COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.