DATE OF BIRTH: ONLY THE PATIENT'S DATE OF BIRTH WAS PROVIDED THEREFORE A DEFAULT DATE OF BIRTH OF (B)(6) 1941 WAS LISTED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO AN UNKNOWN LOT NUMBER FOR DIFFICULT/UNABLE TO OPERATE. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR CHECK DUE TO AN UNKNOWN LOT NUMBER FOR DIFFICULT/UNABLE TO OPERATE. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER?S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.
D
Patient 1
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF UNSPECIFIED BD PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION AND WAS INVOLVED WITH A SERIOUS INJURY IN THE FORM OF HYPERGLYCEMIA. NO ADDITIONAL INFORMATION SUGGESTING THE LAY USER/CONSUMER SOUGHT/RECEIVED MEDICAL INTERVENTION HAS BEEN PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. VERBATIM: BLOOD SUGAR LEVELS WERE HIGH [BLOOD GLUCOSE INCREASED]. THE PATIENT DID NOT ADMINISTER BASAGLAR DUE TO A POSSIBLE ISSUE WITH KWIKPEN DEVICE, NS (BLOOD GLUCOSE INCREASED) [PRODUCT DOSE OMISSION]. CASE DESCRIPTION: THIS SOLICITED CASE, REPORTED BY A CONSUMER WHO WAS PARTICIPATING IN A PATIENT ASSISTANCE PROGRAM (PAP), CONCERNED AN (B)(6) YEAR-OLD FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED INSULIN GLARGINE (BASAGLAR) INJECTIONS VIA PRE-FILLED PEN (KWIKPEN). DOSAGE REGIMEN, ROUTE OF ADMINISTRATION, INDICATION FOR USE AND START THERAPY DATE WERE NOT REPORTED. ON (B)(6) 2020, SHE HAD AN ISSUE WITH FOUR KWIKPENS FROM THE SAME BOX AND LOT NUMBER AS INSULIN GLARGINE WAS NOT BEING DISPENSED, DUE TO THIS, IT WAS BELIEVED INSULIN GLARGINE DOSE WAS MISSED (PC:5055320/LOT NUMBER:D015661A). BD NEEDLES 23GX4MM WERE USED AND PRIMING WITH TWO UNITS WAS PERFORMED PRIOR EVERY INJECTION. THE REPORTING CONSUMER DID NOT PROVIDE CAUSALITY ASSESSMENT BETWEEN THE EVENTS AND INSULIN GLARGINE BUT RELATED THE EVENTS TO THE SUSPECT KWIKPEN. DUE TO SAME PATIENT. DISTRIBUTOR STATEMENT: THE EVENTS BLOOD GLUCOSE INCREASED AND PRODUCT DOSE OMISSION ARE NOT REASONABLY POSSIBLY RELATED TO INSULIN GLARGINE BECAUSE BLOOD GLUCOSE INCREASED IS COMMONLY ASSOCIATED WITH DIABETES MELLITUS, THE APPROVED INDICATION FOR THIS DRUG, AND PRODUCT DOSE OMISSION IS EXTERNAL TO DRUG ACTION.
Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)