MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-24 for FREESTYLE TEST STRIPS GDH-PQQ, FREESTYLE METER manufactured by Abbott Diabetics Care Inc..
[1637402]
The problems started in 2004 with occasional hypoglycemic episodes which included loss of consciousness. The episodes became more frequent with very unusual behavior. Talked to doctors regarding his low blood sugars because (b) (6) could not understand why it would drop so low! The doctors did nothing but, told us to disconnect his pump and use a glucagon injection. I took (b) (6) to the boston clinic in (b) (6) 2007 and sent many glucose meters to be checked out by abbott lab due to the inaccurate readings of highs and lows. They found nothing wrong with the meters but gave no answers to the uncontrollable blood sugars. We used 12 glucagon injections in 8 months and called 911 for medstar ambulance for help!! (b) (6) suffered terribly and was not the same person anymore! He had seizures, loss of memory and anxiety attacks. He was most of all very upset that he could not figure out what was going on with his health, and he took very good care of himself. He was on the medtronic minimed paradigm pump and was very good about watching his carbohydrate intake. We would find him passed out with no warning and completely unresponsive! Frank was very savvy pump user, and the pump trainer in boston was impressed with his pump skills. We had many emergency situations with blood sugars as low as 28 and (b) (6) would argue with us and had no recollection of what happened. He would behave as if he was drunk and each episode became worse which was destroying him each time and took so much out of him!!! I was with (b) (6) at 3:00 in the morning and made him a sandwich because he felt like his blood sugar was low. At 4:00, i checked on him, and he said he was fine and for me to go to bed. In the morning i went to check on him and found him face down in his room at 9:34 am between his dresser and bed. I ran to get a glucagon injection which i gave him. My daughter came over, she lives on the next block and flipped (b) (6) over, his face was blue when we turned (b) (6) over. She called 911 and tried to do cpr!! The ems came and took (b) (6) to the hospital, where our worst nightmare came true. My wonderful, handsome, kind, loving son (b) (6) was gone on (b) (6) 2007. (b) (6) was a juvenile diabetic from the age of (b) (6) and never suffered like he did in the last year of his life!! He had no heart, kidney or major complications from his diabetes!! Medtronic paradigm insulin pump (b) (4), conf b8s4, (b) (4), medtronic mini med quick set mmt-396 lot 2202145, smith and nephew iv prep antiseptic wipe, matisol liquid adhesive, detachol adhesive remover, the freestyle glucose meters (b) (6) used are lot g102a5, (b) (4), lot 02kd44d, (b) (4), lot 01k61d, (b) (4), (b) (4), (b) (4), freestyle lot c307a, (b) (4), medtronic mini med b&d (b) (4) these are some meters that we have the empty boxes. The glucose meter we have was sent to (b) (6) in (b) (6) 2007 due to problems with the other. The meter we sent had most of (b) (6) glucose readings. When i called them to tell them (b) (6) died, they insisted i send them the meter and test strips! They even sent packaging to return everything, i did not send it to them!!! I have all the test strips and the meter he was using when he died which was the (b) (4) freestyle flash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016514 |
| MDR Report Key | 1741354 |
| Date Received | 2010-06-24 |
| Date of Report | 2010-06-16 |
| Date of Event | 2007-07-16 |
| Date Added to Maude | 2010-07-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREESTYLE TEST STRIPS GDH-PQQ, FREESTYLE METER |
| Generic Name | GLUCOSE TEST STRIPS |
| Product Code | LZG |
| Date Received | 2010-06-24 |
| Lot Number | 0702225 |
| ID Number | ART05051 REV. D 03/06 |
| Device Expiration Date | 2009-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | MEDTRONIC PARADIGM INSULIN PUMP |
| Generic Name | NONE |
| Product Code | LZG |
| Date Received | 2010-06-24 |
| Model Number | MMT-515 L NAS, CONF B8S4 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | MEDTRONIC MINI MED QUICK SET |
| Generic Name | NONE |
| Product Code | FPA |
| Date Received | 2010-06-24 |
| Catalog Number | MMT-396 |
| Lot Number | 2202145 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | MATISOL LIQUID ADHESIVE |
| Generic Name | NONE |
| Product Code | KMF |
| Date Received | 2010-06-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | DETACHOL ADHESIVE REMOVER |
| Generic Name | NONE |
| Product Code | KOX |
| Date Received | 2010-06-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | FREESTYLE GLUCOSE METERS |
| Generic Name | NONE |
| Product Code | NBW |
| Date Received | 2010-06-24 |
| Lot Number | G102A5, DAGK0 7-61103 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | FREESTYLE GLUCOSE METERS |
| Generic Name | NONE |
| Product Code | NBW |
| Date Received | 2010-06-24 |
| Lot Number | 02KD44D,DAGK031-616687 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 7 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | FREESTYLE GLUCOSE METERS |
| Generic Name | NONE |
| Product Code | NBW |
| Date Received | 2010-06-24 |
| Lot Number | 01K61D,T-G072-63865,R-F028-620 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 8 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | FREESTYLE |
| Generic Name | NONE |
| Product Code | NBW |
| Date Received | 2010-06-24 |
| Lot Number | C307A,K-E078-61359 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 9 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | MEDTRONIC MINI MED B&D |
| Generic Name | NONE |
| Product Code | NBW |
| Date Received | 2010-06-24 |
| Lot Number | 023470-3198B |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 10 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Brand Name | FREESTYLE FLASH |
| Generic Name | NONE |
| Product Code | NBW |
| Date Received | 2010-06-24 |
| ID Number | DAGK027-61103 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 11 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETICS CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US 94502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening; 3. Other | 2010-06-24 |