MAUDE Adverse Event Report: GLUCOLA TESTING SOLUTION

Device Problem Insufficient Information (3190)

Patient Problems Death, Intrauterine Fetal (1855); Complaint, Ill-Defined (2331)

Event Date 08/13/2013

Event Type  Death  

Event Description

Death of viable infant (intrauterine) shortly after product was used.I was told by the obgyn to do the 3 hours glucola testing during pregnancy.I initially did not want to do this test but i was told that it is mandatory during pregnancy.The obgyn office that gave me the lab order is (b)(6) obstetric gynecology (dr.(b)(6)), located at (b)(6).The lab name is (b)(6).I went to the lab at 8am ((b)(6) 2013).The nurse drew blood and shortly after he gave me the glucose drink.I drank that.He told me that i am not allowed to drink or eat anything for another 3 hours (not even water) while they kept drawing blood for another three times (9, 10, 11 am).I felt sick all this time i had to wait for the blood draws.After i left the lab, infant started moving erratically at times.She had moved a lot during the night after the glucola testing.The morning after i had the test done ((b)(6) 2014), the infant died.I went to the labor and delivery dept at the hospital and nurses and doctors there confirmed the stopping of the heartbeat ((b)(6) 2013 at 2:00am).I know of another woman that lost her child through uterine fetal demise approx 2 hours after the 3 hour glucola testing too.A lot of pregnant women i know felt very ill after drinking the glucose drink before the blood draw.I believe research needs to be conducted and this case investigates to check the connection between the timing of the glucola test and uterine fetal demise (stop of heart beat).If you need i could send you the placenta path report that shows no medical reason for the infant demise.I am not planning on starting any lawsuits.I am just concerned that the consumption of this glucose drink for the dm testing will end the life of some other children.Please update me if this correlation is going to be further investigated.Thank you! quantity: 1 bottle; frequency: 1 time; how was it taken: by mouth.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Did the problem return if the person started taking or using the product again: will not take it.

• Brand Name: GLUCOLA TESTING SOLUTION
• Type of Device: GLUCOLA TESTING SOLUTION
• MDR Report Key: 4235578
• MDR Text Key: 4974558
• Report Number: MW5038978
• Device Sequence Number: 1
• Product Code: CGA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Treatment: PRENANTAL VITAMINS
• Patient Outcome(s): Death
• Patient Age: 34 YR
• Patient Weight: 98