MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK POCKET COMPASS

Catalog Number 04658051160

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient reported that he was questioning the accuracy of the bolus advice provided by the pocket compass software.No adverse event was reported.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.Product will not be returned.

Manufacturer Narrative

One palm centro device (sn (b)(4)) with installed accu-chek pocket compass software (v 4.0.0.5 ptv2.4) was received.A backup of the device data was generated and all logfiles of the accu-chek pocket compass software were read out.The customer allegation 'palm device is not calculating carb correction properly' could not be confirmed during the investigation of the accu- chek pocket compass software logfiles.The given examples in the problem description for the wrong bolus calculation didn't had enough information to reconstruct the bolus calculation.Further more in the logfiles didn't contain the data of the given examples in the problem description thus a reconstruction of complaint bolus calculation is not more possible.While the bolus calculation is depending on different parameters, which e.G.Has to be setup in the accu-chek pocket compass (bolus calculator setup / factors) additional bolus calculations were not performed, because they would not reflect the case described by the customer.In summary the case will be assessed as not verified because the reported failure could not be confirmed with the available information.

• Brand Name: ACCU-CHEK POCKET COMPASS
• Type of Device: ACCU-CHEK POCKET COMPASS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim 6829 8; GM 68298
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3723896
• MDR Text Key: 4330112
• Report Number: 1823260-2014-02343
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04658051160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2014
• Initial Date FDA Received: 04/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASIX; CLONIDINE; HUMALOG; AMLODIPINE; LOSARTAN; HEARING AID; GLUCOSAMINE; HYDROCHLOROTHIAZIDE; BABY ASPIRIN; LIPITOR; METOPROLOL; GABAPENTIN
• Patient Age: 075 YR
• Patient Weight: 104