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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® GUIDE TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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ROCHE DIABETES CARE, INC. ACCU-CHEK ® GUIDE TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Catalog Number 07453736001
Device Problem Insufficient Information (3190)
Patient Problem Hyperglycemia (1905)
Event Date 01/23/2022
Event Type  Injury  
Event Description
The caller reported that he began feeling high blood glucose symptoms of vomiting, nausea, and diarrhea on (b)(6) 2022.His meter was reading in the high 200's mg/dl's.On (b)(6) 2022 at approximately 8:00am the customer received a blood glucose result in the mid 200's mg/dl.The exact result was unknown.The customer was still experiencing high blood glucose symptoms and did not eat much for breakfast.The caller reported that he took his normal 35 units of tresiba insulin, but he did not take his humalog insulin based on the guide test result being in the 200's mg/dl.The customer alleged that reading of 200's mg/dl was lower than expected, which is why he did not take his humalog insulin.At 6:00pm the customer became severely ill and was having trouble walking, the customer tested his blood glucose on the guide system and received a result of 287 mg/dl.The customer's parent's called for an ambulance.The emt's arrived within 15 minutes and received a blood glucose result of 500 mg/dl on their professional meter.The customer does not know if he lost consciousness at any time.The emt's transported the customer to the hospital.On the way to the hospital the emt's tested the customer and received a result of 382 mg/dl.Upon arrival at the hospital, the customer received a lab result of 582 mg/dl and was diagnosed with diabetic ketoacidosis.The hospital treated the customer with an unknown insulin iv.The customer was discharged from the hospital on (b)(6) 2022 and his blood glucose result was 174 mg/dl.
 
Event Description
The caller reported that he began feeling high blood glucose symptoms of vomiting, nausea, and diarrhea on (b)(6) 2022.His meter was reading in the high 200's mg/dl's.On (b)(6) 2022 at approximately 8:00am the customer received a blood glucose result in the mid 200's mg/dl.The exact result was unknown.The customer was still experiencing high blood glucose symptoms and did not eat much for breakfast.The caller reported that he took his normal 35 units of tresiba insulin, but he did not take his humalog insulin based on the guide test result being in the 200's mg/dl.The customer alleged that reading of 200's mg/dl was lower than expected, which is why he did not take his humalog insulin.At 6:00pm the customer became severely ill and was having trouble walking, the customer tested his blood glucose on the guide system and received a result of 287 mg/dl.The customer's parent's called for an ambulance.The emt's arrived within 15 minutes and received a blood glucose result of 500 mg/dl on their professional meter.The customer does not know if he lost consciousness at any time.The emt's transported the customer to the hospital.On the way to the hospital the emt's tested the customer and received a result of 382 mg/dl.Upon arrival at the hospital, the customer received a lab result of 582 mg/dl and was diagnosed with diabetic ketoacidosis.The hospital treated the customer with an unknown insulin iv.The customer was discharged from the hospital on (b)(6) 2022 and his blood glucose result was 174 mg/dl.
 
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Brand Name
ACCU-CHEK ® GUIDE TEST STRIPS
Type of Device
BLOOD GLUCOSE MONITORING TEST STRIPS
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIABETES CARE, INC.
9115 hague road
na
indianapolis IN 46250 1025
Manufacturer Contact
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key13509533
MDR Text Key286053326
Report Number3011393376-2022-00466
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number07453736001
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/25/2022
Initial Date FDA Received02/10/2022
Supplement Dates Manufacturer Received04/12/2022
Supplement Dates FDA Received04/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Patient Sequence Number1
Treatment
HUMALOG INSULIN; LISINOPRIL; METROPROLOL; TRESIBA
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age43 YR
Patient SexMale
Patient Weight81 KG
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